MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problem Hernia (2240)

Event Date 12/08/2020

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, no lot number was reported. After surgery, the patient returned to the hospital on or about (b)(6) 2020, and was diagnosed with progressively enlarging recurrent ventral hernia, intraabdominal adhesions, and chronic abdominal pain. During the procedure of (b)(6) 2020, the patient underwent an open repair recurrent ventral, excisional debriding of abdominal wall with removal of mesh, small bowel resection, and placement of additional mesh. Dense adhesions on the mesh were found. 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: 14435243
• MDR Text Key: 292025344
• Report Number: 1000306051-2022-00092
• 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