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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL MESH, SURGICAL

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SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL MESH, SURGICAL Back to Search Results
Model Number UNKNOWN PERMACOL PRODUCT
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Incontinence (1928); Necrosis (1971); Pain (1994); Hernia (2240); Post Operative Wound Infection (2446); Bowel Perforation (2668); No Code Available (3191)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
Title further insights into the treatment of perineal hernia based on a the experience of a single tertiary centre source the authors. Colorectal disease published by john wiley & sons ltd on behalf of association of coloproctology of great britain and ireland, volume 22, 2020 (694¿702) date of online acceptance: 8 january 2020. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of a study performed about the evolution of a technique for repair of perineal hernia by analyzing the experience in a tertiary referral center, biological mesh was used in 18 out of a total 34 patients. A cross-linked biological mesh was used in 4 out of the 18 patients and complications were noted. 1 patient underwent relaparotomy because of iatrogenic small bowel perforation following adhesiolysis. There were 5 patients that had perineal wound complications. 3 had dehiscence, 2 had infection, and 1 had necrosis. All perineal wound infections were successfully treated with antibiotics (2) and percutaneous drainage of fluid collections (1). There were 7 recurrent perineal hernia after a median of 33 months, where recurrence of perineal hernia occurred in 1 out of 4 patients with cross-linked biological mesh. Re-repair after failed biological mesh using transperineal synthetic mesh was performed in four of seven patients. One patient with a cross-linked biological mesh had developed urinary incontinence and pain in a standing position caused by displacement of the mesh, which was treated by laparoscopic re-fixation of the mesh. Perineal infection occurred in one more patient after biological mesh repair following re-repair of a recurrence and was treated by antibiotics.
 
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Brand NameMESH TSL - PERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10428996
MDR Text Key203862905
Report Number9615742-2020-01849
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 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
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 Received08/03/2020
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: 08/19/2020 Patient Sequence Number: 1
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