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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number P101520
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Edema (1820); Ischemia (1942); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); No Code Available (3191)
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 recurrent ventral hernia. It was reported that after implant, the patient experienced contracted mesh and adhesions. Post-operative patient treatment included removal surgery.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a recurrent ventral hernia. It was reported that after implant, the patient experienced contracted mesh and adhesions. Post-operative patient treatment included removal surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
MDR Report Key8446425
MDR Text Key139667297
Report Number9615742-2019-00634
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,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2012
Device Model NumberP101520
Device Catalogue NumberP101520
Device Lot Number08B210E
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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