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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 UNK-PERMACOL
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Inflammation (1932); Miscarriage (1962); Nausea (1970); Pain (1994); Tinnitus (2103); No Code Available (3191)
Event Date 03/04/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, following a laparoscopic ventral mesh rectopexy, while being applied at the rectum, the device caused many health problems. Patient's health had deteriorated since having it in her body. She had been unable to have sex without significant pain since the device was inserted. Her rectum did not work, and had to take significantly more laxatives and use irrigation to try to evacuate bowel. She also felt a palpable lump from inside her vaginal wall, and the attaching metal clips. Also after this operation she had a different mesh inserted, which will be reported separately as it gave her further problems. She suffered a miscarriage after the biological mesh and had been unable to get pregnant since. She believed that there was an inflammatory/ foreign body response. Anytime anything is near the mesh, she experienced intense pain, nausea, hot flushes. Her hair had also been falling out in clumps. She had ear problems including tinnitus. She did not have these issues prior to the mesh insertion. The device was in a knot according, it is not in the recto vaginal septum but at level with the top of vagina. The patient required an ileostomy due to a damaged rectum and vagina. The patient also had recurrent hospital stays. The patient had incurred a permanent injury.
 
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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 Key7464499
MDR Text Key106609516
Report Number9615742-2018-01030
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
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: 04/26/2018 Patient Sequence Number: 1
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