MAUDE Adverse Event Report: LIFECELL SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1); MESH, SURGICAL

Catalog Number	CON1006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to lifecell for evaluation.The internal investigation into strattice lot sp200010 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the 539 devices released to finished goods for lot sp200010, 314 have been distributed.Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined.Other surgical or patient factors could also contribute to this event.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
It was reported that a patient underwent a breast augmentation with strattice.Within days or weeks, the patient began to experience inflammation and an abscess with pus associated with the strattice.The strattice and the breast implant were removed.Upon examination, the surgeon confirmed that the strattice did not incorporate.Cultures were negative for any infections.
Event or Problem Description
It was reported that patient seen on jan 28th with mild swelling of left breast then returned to their office feb 5 with an abscess visible through the skin.The implant and strattice were removed that day in their office.When wound was opened there was a large amount of pus, not foul smelling, no redness in skin or fevers.The strattice was not adhered to tissues and seemed floppy and loose.It was removed along with the pus and implant.2 sets of cultures were obtained, no growth in either.The strattice was loose and floppy even though it had been sutured with pds.The strattice was removed and the pocket irrigated after cultures.The pus was so abundant it surrounded implant and strattice.Patient is fully healed but with some deformity due to contracture of tissues (wound treated with wet to dry packings and allowed to close by secondary intention.

• Brand Name: SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8495943
• Report Number: 1000306051-2019-00064
• Device Sequence Number: 13869080
• Product Code: FTM
• UDI-Device Identifier: 00818410010263
• UDI-Public: 00818410010263
• Combination Product (Y/N): N
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 06/30/2020
• Device Catalogue Number: CON1006
• Device Lot Number: SP200010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION; NO INFORMATION
• Outcome Attributed to Adverse Event: Required Intervention