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

Model Number UNKNOWN MESH PRODUCT

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

Patient Problems Pain (1994); Burning Sensation (2146); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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, post operatively, patient had hernia surgery and ended back in hospital the following day with pain and problems and has contained ever since burning stabbing bowel.Habits changed and patient cannot walk some days.Multiple medication days off work.

• Brand Name: UNKNOWN MESH PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14174184
• MDR Text Key: 289877429
• Report Number: 9615742-2022-00345
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2022

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 Model Number: UNKNOWN MESH PRODUCT
• Device Catalogue Number: UNKNOWN MESH PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• 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