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

Model Number UNK SOFRADIM ME

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: ugykp (lot #pgc00171), 72404210 perigee system with intepro (lot# 45201013 and 72403830), monarc subfascial hammock (lot# 459504045).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of uterine prolapse, cystocele rectocele, and stress urinary incontinence.It was reported that after implant, the patient experienced worsening vaginal pain, significant amount of prolapse and 3rd degree cystocele.Post-operative patient treatment included robotic sacral colpopexy with diagnostic cystoscopy.The product had been used with 72404210 perigee system with intepro, lot# 45201013 and 72403830, monarc subfascial hammock, lot# 459504045.

• Brand Name: SOFRADIM MESH
• 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: 8886174
• MDR Text Key: 154100007
• Report Number: 9615742-2019-02809
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: UNK SOFRADIM ME
• Device Catalogue Number: UNK SOFRADIM ME
• Device Lot Number: ZGB00240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/12/2019
• Date Device Manufactured: 02/01/2006
• 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): Required Intervention
• Patient Weight: 84