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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 UNKNOWN PERMACOL PRODUCT
Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
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. (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 hernia. It was reported that after implant, the patient experienced recurrence, infection, subcutaneous pocket filled with pus and necrotic tissue, mesh unincorporated centrally, dense adhesions in colon and throughout abdomen, capsule was thick and inflamed with areas of necrosis, bowel present at the base of wound but was all matted together and did not allow entrance into abdominal cavity, developed 5 cm eschar, large abdominal wall abscesses, creamy pus, inflammatory tissue, abdominal pain, distended fluid filled stomach, purulent exudate through abdomen, rectal stump covered in pus, rectal stump leaking and suspected source of peritonitis, yellowish greenish exudate, small bowel obstruction, serous fluid and ascites, chronic thickening of bowel, and distended gall bladder. Postoperative patient treatment included exploration of abdominal wound with evacuation, exploratory laparotomy, lysis of adhesions, peritoneal lavage, rigid proctoscopy, debridement and removal of mesh.
 
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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
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 Key9189188
MDR Text Key162626333
Report Number9615742-2019-03414
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PERMACOL PRODUCT
Device Catalogue NumberUNKNOWN PERMACOL PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
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: 10/14/2019 Patient Sequence Number: 1
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