MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number	CON3006
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation of lot sp100324 includes: method of evaluation: review of information as reported.Review of the device history records and complaint history records associated with lot sp100324.Results of evaluation: review of reported information.Review of lot processing history and complaint history records for lot sp100324 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release.As of 12 mar 2018, no other complaint has been reported to lifecell against lot sp100324.As of 12 mar 2018, of the (b)(4) devices released to finished goods for lot sp100324, all (b)(4) devices were distributed with (b)(4) devices reported to be implanted.Conclusion: as noted by the surgeon, the patient did not have good vascularization at the time of implant and the only areas of attachment were where the mesh was sutured in place.Based on our internal review of the device processing history, the lot met qc criteria for product release.Lot sp100324 was aseptically processed and terminally sterilized within process parameters.No deviation was encountered in association with the reported event.No other complaint has been reported to lifecell against lot sp100324.The event is unlikely related to strattice.This concludes our investigation.
Event or Problem Description
It was reported that on (b)(6) 2016, a female patient underwent bilateral capsular contracture repair with breast implants and statice.Drains had been placed and maintained until the 24-hour output was 20cc or less.The patient noted a palpable nodule in her left lateral breast within six months after this surgery, but was otherwise pleased with her results.There is no history of chemotherapy or radiation treatment.The patient, now (b)(6), complained of "puckering, " would like to be softer, more symmetric and improve the areolar puckering.The surgeon suspected that the mesh had folded near the suture line.On (b)(6) 2018, the device was found to be unincorporated and was surgically removed.The patient did not have good vascularization at the time of implant.The only areas of attachment were where the mesh was sutured in place.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 7342849
• Report Number: 1000306051-2018-00037
• Device Sequence Number: 16650075
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: CON3006
• Device Lot Number: SP100324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/15/2018
• 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: Required Intervention
• Patient Age: 33 YR