FDA.reportPublic FDA data

MAUDE MDR 5996665

MDR report key
5996665
Report number
9617229-2016-00136
Event key
0
Event type
3
Date received
2016-10-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SUZANNE WOJCIK
Address
301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US
Phone
737-737-7372
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RND RE-STER SIZER 45, 460SIZER, MAMMARY, BREAST IMPLANT VOLUMEALLERGAN (COSTA RICA)MRDMSZ454602269085R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-0401. O

Event Narratives#

N

Patient 1

MEDWATCH SUBMITTED TO THE FDA ON 10/04/2016. IT IS CURRENTLY UNKNOWN IF THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEWED. DHR SUMMARY: REVIEW OF DHR FOR WORK ORDER (B)(4) DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE EVENT. ALL BREAST IMPLANT SIZER WERE REVIEWED AS PART OF THE ASSEMBLY OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT ASSEMBLY MET THE REQUIRED SPECIFICATIONS. DHR FOR WORK ORDER (B)(4) INDICATES THAT THERE WAS A REPROCESS ON THE PRIMARY PACKAGING OPERATION. THE REPORTED DEVICE WAS REPROCESSED THROUGH WORK ORDER (B)(4) AND ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES WERE IDENTIFIED THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE EVENT. DHR FOR WORK ORDER (B)(4) INDICATES THAT THERE WAS A REPROCESS IN THE PRIMARY PACKAGING OPERATION, HOWEVER THIS WAS COMPLETED ON A DIFFERENT SERIAL NUMBER AND THIS HAS NO RELATION NEITHER CAN CAUSE THE REPORTED EVENT. THE DHR ASSEMBLY REPORT FROM SAP WAS VERIFIED AND ONE DEVICE WAS SCRAPPED DURING THE ASSEMBLY PROCESS (GS) WHICH IS NOT RELATED TO THE REPORTED EVENT. IN ADDITION, DHR FOR SHELL RUN NUMBER (B)(4) DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE EVENT. ALL SHELLS WERE REVIEWED AS PART OF THE SHELL FABRICATION OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT FABRICATION MET THE REQUIRED SPECIFICATIONS. ACCORDING TO THE INFORMATION GATHERED DURING THE DHR REVIEW, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICES FROM WORK ORDER (B)(4) WERE ASSEMBLED IN ACCORDANCE WITH ALLERGAN MEDICAL PROCEDURES AND SPECIFICATIONS. THE REPORTED DEVICE WAS INTACT AT THE TIME OF PRODUCTION AND MET THE REQUIRED SPECIFICATIONS. DEVICE LABELING: NATRELLE? RE-STERILIZABLE SIZERS ARE INTENDED FOR A MAXIMUM TEN (10) ADDITIONAL USES AFTER INITIAL USE FOLLOWING VALIDATED PROCEDURES FOR CLEANING, DISINFECTING AND RE-STERILIZATION. COMPLETE SIZER RE-STERILIZATION RECORD CARD PROVIDED WITH THE DEVICE AFTER EACH RE-STERILIZATION PROCESS. THE NAME OF PERSON PERFORMING THE RE-STERILIZATION AND DATE OF RE-STERILIZATION SHOULD BE RECORDED ON THE CARD. THE SIZER RE-STERILIZATION RECORD CARD SHOULD ACCOMPANY THE DEVICE AT ALL TIMES. REPEAT USE THESE PRODUCTS ARE INTENDED FOR TEN (10) ADDITIONAL USES AFTER INITIAL USE AND ONLY AFTER ADEQUATE CLEANING, DISINFECTING AND RE-STERILIZATION BY VALIDATED TECHNIQUES. DO NOT REUSE RE-STERILIZABLE SIZERS MORE THAN TEN (10) TIMES AFTER INITIAL USE.

D

Patient 1

COMPANY REPRESENTATIVE REPORTED ON BEHALF OF HEALTH PROFESSIONAL THAT A RESTERILIZABLE SIZER "BUSTED" WHILE BEING INSERTED INTO A PATIENT. THE SIZER HAD BEEN PREVIOUSLY USED 8 TIMES. FOLLOW UP FINDINGS REVEALED GEL MADE CONTACT WITH THE PATIENT AS THE PHYSICIAN HAD TO CLEAN OUT THE POCKET AFTER REMOVING THE "BUSTED" SIZER. SURGERY WAS COMPLETED WITH A BACK-UP SIZER.

N

Patient 1

MEDWATCH SUBMITTED TO THE FDA ON 10/11/2016. RECEIVED CONFIRMATION FROM THE PHYSICIAN'S OFFICE THAT THE EXPLANTED DEVICE WAS DISCARDED AND, THEREFORE, IS NOT AVAILABLE FOR FURTHER ANALYSIS. ADDITIONAL DATA: DEVICE AVAILABLE FOR EVALUATION?., EVALUATION CODES.

D

Patient 1

COMPANY REPRESENTATIVE REPORTED ON BEHALF OF HEALTH PROFESSIONAL THAT A RESTERILIZABLE SIZER "BUSTED" WHILE BEING INSERTED INTO A PATIENT. THE SIZER HAD BEEN PREVIOUSLY USED 8 TIMES. FOLLOW UP FINDINGS REVEALED GEL MADE CONTACT WITH THE PATIENT AS THE PHYSICIAN HAD TO CLEAN OUT THE POCKET AFTER REMOVING THE "BUSTED" SIZER. SURGERY WAS COMPLETED WITH A BACK-UP SIZER.