MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

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

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported complications 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.

Event Description

It was reported through a legal event that a (b)(6) female patient underwent hernia repair surgery on or about (b)(6) 2019.During surgery, the surgeon implanted a strattice firm mesh.After surgery, the patient was diagnosed with an abdominal wall necrotizing soft tissue infection and had a wound debridement and placement of additional mesh on (b)(6) 2019.On (b)(6) 2019, due to the chronic abdominal wound infection, the patient had a wound debridement and placement of a wound vac.On (b)(6) 2020, she had an explant of mesh, repair of enterocutaneous fistula and repair of parastomal hernia.This record is associated with the second mesh implanted on (b)(6) 2019.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14136565
• MDR Text Key: 289449575
• Report Number: 1000306051-2022-00050
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2022
• 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 Age: 72 YR
• Patient Sex: Female