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 Necrosis (1971); Seroma (2069); Hernia (2240)

Event Date 06/01/2012

Event Type  Injury  

Event Description

Limited information was reported through a legal event that on (b)(6) 2011 a (b)(6) female underwent a procedure to treat hernia reoccurrence and adhesions. During the procedure, strattice was implanted. Lysis of adhesions and bilateral component separation was performed. On (b)(6) 2012 a second revision surgery was performed and strattice was explanted. Fat necrosis was noted and excised over the mesh and seroma was noted. In 2019 the patient underwent additional surgeries for hernia repair. No other information was reported.

Manufacturer Narrative

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 could not be determined. Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation. To date, no additional information has been received. No further actions are required, a nonconformance was not confirmed.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14435306
• MDR Text Key: 292025587
• Report Number: 1000306051-2022-00098
• 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: 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

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2022
• 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 Treatment Data

Date Received: 05/19/2022 Patient Sequence Number: 1

Treatment

NO INFORMATION REPORTED