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

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.

• Brand Name: MESH TSL - PELVICOL
• Type of Device: MESH, 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 Key: 8551844
• MDR Text Key: 143119755
• Report Number: 9615742-2019-01484
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEL415
• Device Catalogue Number: PEL415
• Device Lot Number: 07B08-3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 60