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NOTICE OF CUSTOMER COMPLAINT

Complaint # Date Reported
Customer Name: Customer Order Number:
Reported By: Phone Number:
Customer Address:
Catalog Number/Descrpton: !n"ury/#a$ety Concern: %es No
Complant Ta&en By 'Name( Ttle):
Complaint Description
NON-CONFORMIN CONDITION REPORTED
Complant to be n*estgated: %es / No NCR + ,,,,,,, CAPA + ,,,,,,,,
!$ -No. e/planaton 0hy and attach $ more space
necessary:
Orgnator 'sgn):
!ERIFICATION
#amples Rec1d2 %es No De$ect 3er$ed2 %es No
4ot Number: Reportable 5*ent2 %es No by:,,,,,,,,
6DR Number: Date Reported: Attach ratonale 0hy No s selected7
8ty A$$ected: !n*estgaton complete %es No
Recall 0arranted2 %es No
Attach ratonale 0hy No s selected7
Date o$ $ollo09up report due $ re:ured to No
ans0er abo*e;
ACTION"RESULTS
'attach test results or n*estgaton summary or addtonal $orms $ applcable)
Reply to Customer: No Reply By Telephone
<rtten Response 'attach copy)
Correct*e Acton Re:uested2 %es No
CA Re$+ '$ applcable):
Complant Closure '#gn( Date)
US FDA# =>C?R @>A;= '): #erous( ad*erse health conse:uence means any sgn$cant ad*erse e/perence( ncludng
those that may be ether l$e9threatenng or n*ol*e permanent or long9term n"ures( but e/cludng n"ures that are
nonl$e9threatenng and that are temporary and reasonably re*ersble2 %es / No B !$ C%esC o to MDR and $P%&'%
Medical De(ice Reportin) * Medical De(ice !i)ilance S+stem and $P%%', Recall * -it.dra/al Proced0re'
?orm 8?9 /// Re*; A Date: @/>=/>D
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1ealt. Canada# #OR E@9=@= FG'>): #a$ety related ssue 0th ths complant2 %es / No
!$ C%esC ; o to $P%&'% Medical De(ice Reportin) * Medical De(ice !i)ilance S+stem and $P%%', Recall *
-it.dra/al Proced0re Also re*e0 http://la0s;"ustce;gc;ca/en/sho0doc/cr/#OR9E@9=@=/bo9ga:l,>9
gb:s,>A//en+anchorbo9ga:l,>9gb:s,>A
?orm 8?9 /// Re*; A Date: @/>=/>D