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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 UNK-PERMACOL
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); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. 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
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
justin ellis
60 middletown ave.
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/30/2022
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 NumberUNK-PERMACOL
Device Catalogue NumberUNK-PERMACOL
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2022
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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