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 11/05/2018

Event Type  Injury  

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.

Event Description

Limited information was reported through legal that a (b)(6) female patient underwent hernia repair surgery on (b)(6) 2018.Dr.(b)(6) performed the incarcerated incisional hernia repair at the (b)(6) medical center, (b)(6).During the surgery, the surgeon implanted a strattice 20 x 30 cm mesh in her.The lot and batch numbers and catalog and serial numbers for that mesh are unknown at this time.The patient underwent several revision surgeries over the next year due to the strattice mesh, beginning on (b)(6) 2018, including debridement of her wound, placement of a wound vac and mesh removal.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14136507
• MDR Text Key: 289450222
• Report Number: 1000306051-2022-00049
• 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

• 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
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/18/2022
• 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: 41 YR
• Patient Sex: Female