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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Hernia (2240); No Code Available (3191)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
Title: a low incidence of perineal hernia when using a biological mesh after extralevator abdominoperineal excision with or without pelvic exenteration or distal sacral resection in locally advanced rectal cancer patients source techniques in coloproctology, volume 24, 2020 (855¿861) date of publication online: 8 june 2020. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed, the study aimed to evaluate the outcome of the use of a biological mesh after pelvic reconstruction in patients with advanced rectal cancer. A total of 35 patients were included in the study and all had pelvic floor reconstruction with mesh. Eighteen patients had minor to major would dehiscence, for which treatment was conservative in 8 cases. One patient received antibiotic treatment. A wound dehiscence grade 3 occurred in 9 patients, 5 patients needed vac therapy and the other four patients required reoperation with the use of petal flap in 2 cases. One patient had deep wound infection requiring permacol removal, and perineal hernia. A perineal hernia occurred in three patients and underwent correction of hernia.
 
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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 Key10435224
MDR Text Key203865049
Report Number9617613-2020-00070
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
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: 08/20/2020 Patient Sequence Number: 1
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