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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH TSL - PELVICOL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PEL415
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Irritation (1941); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Injury (2348); Malaise (2359); Prolapse (2475); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Date 04/24/2010
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, multiple medical complications occurred after implant of the device. The product was used for therapeutic treatment of recurrent bladder prolapse, recurrent dysuria and recurrent urinary tract infections. After implant, the patient experienced epigastric/abdominal pain, pubic pain with pudendal nerve injury, pain of the left vaginal fundus, clitoral pain, pelvic pain, hematoma, adenomyosis lesion, lesions of deep peritoneal endometriosis at the torus/left uterosacral ligament, cystocele/prolapse recurrence, recurrent dysuria, malaise during defecation, constipation, difficult micturition, and vesical irritation.

 
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Brand NameMESH TSL - PELVICOL
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key8551844
MDR Text Key143119755
Report Number9615742-2019-01484
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 04/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPEL415
Device Catalogue NumberPEL415
Device LOT Number07B08-3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
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: 04/25/2019 Patient Sequence Number: 1
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