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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SYMBOTEX MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title a (b)(6)-year-old female presented in (b)(6) 2018 with a high output small bowel fistula source gms interdisciplinary plastic and reconstructive surgery dgpw 2019, volume 8, 2019 (2). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of study, a (b)(6)-year-old female presented in (b)(6) 2018 with a high output small bowel fistula and signs of infection at the midline incision and the abdominal wall. Parts of the mesh became visible. After antibiotic pretreatment, re-laparotomy with extirpation of the mesh, adhesiolysis, spare resection of the small bowel including the fistulas, ileoileostomy and reconstruction of the abdominal wall was performed in (b)(6) 2018. From the intraoperative findings it was clear that the mesh eroded the small bowel and caused the fistulas. The postoperative course was again eventful and resulted in fistula formation, but fortunately only a small low-output fistula developed. After three months of intensive wound therapy, the patient was able to handle the low-output fistula like a small stoma and presented in (b)(6) 2018 with complete oral intake and a secretion of less than 5cc per day.

 
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Brand NameUNKNOWN SYMBOTEX MESH
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 Key9519346
MDR Text Key177184231
Report Number9615742-2019-03910
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN SYMBOTEX MESH
Device Catalogue NumberUNKNOWN SYMBOTEX MESH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
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: 12/26/2019 Patient Sequence Number: 1
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