MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX 42X32CM

Model Number SYM4232

Device Problem Detachment Of Device Component (1104)

Patient Problems Hernia (2240); Tissue Breakdown (2681)

Event Date 12/26/2014

Event Type  Injury  

Event Description

(b)(4).The customer reported that the patient had a hernia repair operation on (b)(6) 2014: the patient's tissue was degraded and she had several hernias.On (b)(6) 2014 the patient returned for a second operation: the mesh had come off on one side, hernia re-occurence.The surgeon removed mesh altogether.Lot was requested from the sales rep via email.

Manufacturer Narrative

This complaint is a replacing (b)(4), which was had an initial emdr that was sent with the incorrect site registration.

• Brand Name: SYMBOTEX 42X32CM
• Type of Device: SYMBOTEX
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4406955
• MDR Text Key: 5283972
• Report Number: 9615742-2015-00001
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2015

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: Other
• Device Model Number: SYM4232
• Device Catalogue Number: SYM4232
• Device Lot Number: PNJ0231X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 64 YR