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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 SYM15
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Pain (1994); Scar Tissue (2060); Hernia (2240); Impaired Healing (2378); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: unknown protack (lot # unknown), unknown absorbatack (lot # unknown). 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 laparoscopic therapeutic treatment of a spigelian hernia. It was reported that after implant, the patient experienced adhesions, pain, mesh even treated into defect, recurrence, bilateral spigelian hernias, mesh exposed at open wound, chronic open wound, infected mesh, scar tissue, sinus tract, excessive symptomatic abdominal pannus, staphylococcus aureus, laceration, inflammation, biofilm formed on mesh, and abdominal wall pain. Post-operative patient treatment included lysis of adhesions, explant of mesh, ct scan, hernia repaired with mesh, debridement of wound, scar tissue removed, sinus tract removed, inflamed tissue including umbilicus excised, tissue debridement, diagnostic laparoscopy, removal of tacks, and two clips removed from subcutaneous tissue.

 
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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 Key11349115
MDR Text Key232566771
Report Number9615742-2021-00384
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 02/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device MODEL NumberSYM15
Device Catalogue NumberSYM15
Device LOT NumberPPA0847X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/04/2015
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: 02/19/2021 Patient Sequence Number: 1
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