MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 450CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F450
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: "hair inside the sterile packing".
Event or Problem Description
Healthcare professional reported "hair inside the sterile packing." device was not implanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: weight to the spec, no fiber or hair was observed in the implant, creases fold and wear abrasion.Cloudy and voids in the gel observed after autoclave cycle.Based on the device analysis the final assessment is: no fiber or hair was observed in the implant.
Event or Problem Description
Healthcare professional reported "hair inside the sterile packing." device was not implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 450CC SIZER US
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11289343
• Report Number: 9617229-2021-01587
• Device Sequence Number: 11648577
• Product Code: MRD
• UDI-Device Identifier: 10888628009349
• UDI-Public: 10888628009349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Catalogue Number: MSZ-F450
• Device Lot Number: 3467291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other