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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 Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Swelling (2091); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); 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 parastomal and ventral hernias. It was reported that after implant, the patient experienced recurrence, unhealed abdominal wound with infection, adhesions, small bowel obstruction, abdominal fluid collection, purulent drainage, unincorporated mesh that was freely floating within an abscess, swelling, erythema, fever, abdominal pain, distention, perforated small bowel, enterocutaneous fistulas, chronic focally acute inflammation, focal fat necrosis, and fibroadipose tissue. Post-operative patient treatment included removal surgery, ventral hernia repaired with new mesh, multilayer closure with tissue rearrangement, incision and drainage of abdominal wall wound collection, incision and drainage of abscess, small bowel resection, repair of small bowel injury due to adhesive disease, bilateral rectus sheath block, and bilateral transversus abdominis plane block.
 
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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 Key9283357
MDR Text Key165262216
Report Number9617613-2019-00186
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
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
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 Received11/11/2019
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: 11/06/2019 Patient Sequence Number: 1
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