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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 P101010
Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Seroma (2069); Discharge (2225); Injury (2348); Impaired Healing (2378)
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 incisional ventral hernia. It was reported that after implant, the patient experienced infection, draining seroma with exposed mesh and partial mesh unincorporated with fibrinous exudate.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a recurrent incisional ventral hernia. It was reported that after implant, the patient experienced infection, open wound, draining seroma with exposed mesh and partial mesh unincorporated with fibrinous exudate. Post-operative patient treatment included wound vac, removal of mesh, and revision surgery.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 Key8744229
MDR Text Key149504981
Report Number9615742-2019-02308
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,Followup,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2013
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number10B0701
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: 06/28/2019 Patient Sequence Number: 1
Treatment
PCO3728(LOT#: PJK00114)
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