MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 10CM X 16CM; MESH, SURGICAL

Catalog Number	1016005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/13/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a lifecell strattice mesh strattice after surgery, the patient returned to the hospital on or about (b)(6) 2015, was diagnosed with a recurrent hernia and underwent a mesh revision operation.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional and/or corrected data: b5, d4, g6, h2, h6 internal investigation into strattice lot s11221 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 8/23/22, of the (b)(4) devices released to finished goods for lot s11221, (b)(4) have been distributed with (b)(4) reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up #1 to report on august 10th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is s11221-232.No other information was reported.As reported in the initial: limited information was reported through a legal event that a 68 year old male patient underwent hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a lifecell strattice mesh strattice after surgery, the patient returned to the hospital on or about (b)(6) 2015, was diagnosed with a recurrent hernia and underwent a mesh revision operation.

• Brand Name: STRATTICE LAPAROSCOPIC 10CM X 16CM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14192257
• Report Number: 1000306051-2022-00061
• Device Sequence Number: 11864216
• Product Code: FTM
• UDI-Device Identifier: 00818410012823
• UDI-Public: 00818410012823
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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 Catalogue Number: 1016005
• Device Lot Number: S11221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male