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

Catalog Number 1016002P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hernia (2240)

Event Date 05/26/2020

Event Type  Injury  

Event Description

Limited information was reported through a legal event that a (b)(6) male underwent hernia repair on or about (b)(6) 2019.During the patient¿s surgery, the surgeon implanted him with strattice, lot number (b)(4) (sku 1016002p).After surgery, the patient returned to the hospital on or about (b)(6) 2020 and was diagnosed with recurrent ventral incisional hernia and chronic mesh infection.The (b)(6) 2020, procedure was a robotic laparoscopic repair left and right myofascial cutaneous release, right transverse abdominis release, lysis of adhesions, wound exploration, and debridement of abdominal wall and placement of additional mesh.No other information was reported.

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp200019 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.(b)(4).Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE PERFORATED 10 X 16
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14435323
• MDR Text Key: 292029380
• Report Number: 1000306051-2022-00096
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 1016002P
• Device Lot Number: SP200019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION REPORTED
• Patient Outcome(s): Required Intervention
• Patient Sex: Female