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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM2015
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scarring (2061); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: unknown absorbable 30 count (product id: unknown, lot number: n4a0541x). (b)(4). 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 an abdominal hernia. It was reported that after implant, the patient experienced pain, scarring, dermatitis, induration, fibrosis, granulation, fistula, adhesions, non-healing wound, abdominal wound dehiscence, infection, retained foreign body, foreign body reaction, mesh migration, recurrence, intentional/ bowel obstruction, and perforation. Post-operative patient treatment included resection and additional surgery.

 
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Brand NameSYMBOTEX
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 Key10750825
MDR Text Key213616791
Report Number9615742-2020-02424
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device MODEL NumberSYM2015
Device Catalogue NumberSYM2015
Device LOT NumberPNJ0509X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/04/2013
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: 10/28/2020 Patient Sequence Number: 1
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