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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2030002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Necrosis (1971)
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 first mesh implanted on (b)(6) 2019.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14136496
MDR Text Key289449268
Report Number1000306051-2022-00048
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00818410010393
UDI-Public00818410010393
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2030002
Device Lot NumberSP100617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/25/2022
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: 04/18/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED.
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