MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2); MESH, SURGICAL

Catalog Number	CON2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation of lot sp100540 includes: manufacturing review: review of information as reported, review of the device history records and complaint.History.Records associated with lot sp100540.Results of evaluation: no failure detected.Review of lot processing history and complaint history records for lot sp100540 was unremarkable.There was no processing deviation or nonconformance related to the nature of this complaint.The lot met qc criteria for release, including mechanical testing results.As of (b)(6) 2018, no similar complaint has been reported to lifecell against lot sp100540.As of (b)(6) 2018, of the (b)(4) devices released to finished goods for lot sp100540, (b)(4) devices were distributed with (b)(4) devices reported to be implanted.Evaluation conclusion: known inherent risk of device.Device not returned.Based on our internal review of the device processing history, the lot met qc criteria for product release.The event is unlikely related to strattice bps.Lot sp100540 was aseptically processed, terminally sterilized within process parameters, and met qc release criteria.No deviation was encountered in association with the reported event.No other infection complaint has been reported to lifecell against lot sp100540.[(b)(4) - follow up response recipient cultures (b)(6) 2018.Pdf].
Event or Problem Description
It was reported that a (b)(6) year old female patient underwent revision of right breast with strattice bps due to capsular contracture on (b)(6) 2018.On (b)(6) 2018, the patient presented with post op infection resulting in surgical and medical intervention that day.Cloudy serosanguineous fluid was found around the implant and strattice bps mesh.There were no abscesses or hematoma.Her implant was intact.The pocket was washed out, a drain was placed, the patient was treated with antibiotics, and the strattice bps mesh was explanted along with the implant.The patient has since recovered and was rescheduled for follow up procedure.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 7422467
• Report Number: 1000306051-2018-00047
• Device Sequence Number: 679496
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 05/31/2019
• Device Catalogue Number: CON2006
• Device Lot Number: SP100540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/11/2018
• 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: 49 YR