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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL

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TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL Back to Search Results
Model Number P152030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Hernia (2240); Obstruction/Occlusion (2422); Fibrosis (3167); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, bowel obstruction, and fibrous capsule formed in reaction to the failed hernia mesh. Post-operative patient treatment included revision surgery and mesh removal surgery.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
UK GU11 1EJ
MDR Report Key12650518
MDR Text Key280590676
Report Number9617613-2021-00033
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number10B1509
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/18/2021 Patient Sequence Number: 1
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