MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM; MESH, SURGICAL

Catalog Number	3030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Hernia (2240)
Date of Event	08/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100283 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria.As of 19/oct/2018, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted.Multiple attempts are being made to obtain relevant medical records.Due to the limited information reported, including lack of clinical details by the patient's healthcare professional, a relationship between the strattice and this event could not be determined.The strattice remains implanted.No further actions are required as a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.
Event or Problem Description
It was reported by a patient through voluntary mw5079828 that following implant with one strattice 30x30 hernia mesh on (b)(6) 2015, they developed severe pain and had an infection which resulted in the incision reopened to remove the infection, followed by wound vac therapy for several months.The following year, the patient reported to still have severe abdominal pain which led to a bowel obstruction and then abscess drainage, both in 2017.The patient still experiences more abdominal pain resulting in the return of three hernias, two in the groin and one in the abdominal area.The patient is awaiting revision surgery for all of the hernias in 2018.It was confirmed that this was not reported to lifecell as a complaint at the time of event by "neither" the patient "nor" their health care professional.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8032287
• Report Number: 1000306051-2018-00134
• Device Sequence Number: 1643313
• Product Code: FTM
• UDI-Device Identifier: 00818410011796
• UDI-Public: 00818410011796
• Combination Product (Y/N): N
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• 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: 07/31/2017
• Device Catalogue Number: 3030002
• Device Lot Number: SP100283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/02/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention