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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

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UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/07/2015
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
It was reported through a legal event that a female patient underwent hernia repair surgery on or about (b)(6) 2012 and the surgeon implanted a strattice mesh. After surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with recurrent ventral hernia. On or about (b)(6) 2015, the patient underwent surgery for the excision of the lifecell strattice mesh and lysis of adhesions. Inspection of the mesh showed that the mesh was contracted, the mesh was curled, and there were extensive adhesions. Additional mesh was placed.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key13844151
MDR Text Key287576517
Report Number1000306051-2022-00041
Device Sequence Number1
Product Code FTM
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
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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