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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
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Respiratory Failure (2484); No Code Available (3191)
Event Date 09/01/2018
Event Type  Injury  
Manufacturer Narrative
Title adverse obstetric history is not a risk factor for poor outcome after ventral rectopexy for obstructive defaecation syndrome. Source colorectal disease. 20 (1125-1131), 2018. Date of publication: 01 sept 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature study, after the patients underwent ventral rectopexy (vr) for obstructive defecation syndrome, there were minor and major complications reported. One patient needed transfer to the icu due to respiratory failure. Two further patients required surgical intervention postoperatively: one for an obstructed umbilical hernia and an adhesional small bowel obstruction. Late complications consisted of mesh erosion into the vagina in one patient and pelvic pain in another.
 
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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 Key8260839
MDR Text Key133528138
Report Number9615742-2019-00163
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 foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PERMACOL
Device Catalogue NumberUNKNOWN 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 Received12/21/2018
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: 01/18/2019 Patient Sequence Number: 1
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