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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 P101520
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Inflammation (1932); Scar Tissue (2060); Ulceration (2116); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 recurrence, adhesions, fistula, ulcerated hernia sac, inflammation, fibrosis, devascularized hernia sac. , wound opening, wound dehiscence, small bowel evisceration, exposed intestine, gut failure, calcification, scar tissue, ulcers, and mesh erosion into viscera. Post-operative patient treatment included mesh removal, hernia repair with new mesh, lysis of adhesions, evisceration, takedown/repair of gastrocutaneous fistula, repair of enterotomy of the colonic conduit, primary repair of enterotomy of the colon, excised skin/subcutaneous tissue, right/left myofascial advancement flap, closure of fascia, wound vac, primary skin closure, full-thickness biopsy of the deep abdominal wall ulcers, closure of abdomen in 2 layers, and cholecystectomy.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10379880
MDR Text Key203737181
Report Number9617613-2020-00068
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP101520
Device Catalogue NumberP101520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/07/2020 Patient Sequence Number: 1
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