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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 SYM9
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Emotional Changes (1831); Fever (1858); Inflammation (1932); Pain (1994); Vomiting (2144); Ulcer (2274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

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 incisional hernia. It was reported that after implant, the patient experienced extreme pain, abdominal pain, vomiting, 20-30 episodes of diarrhea per day, omental adhesions to mesh, appendix inflammation, chronic inflammation from mesh, malnourishment, 100-degree fever, marginal ulcer, suffering, injury, and mental pain, and fragmented mesh. Post-operative patient treatment included multiple emergency room visits, transnasal esophagoscopy, lysis of adhesions, hernia repair, ct scan, appendectomy, peripherally inserted central catheter ("picc") placement in arm for malnourishment, admission to the hospital, diagnostic laparoscopy, upper endoscopy, and mesh removal.

 
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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 Key11322243
MDR Text Key231624753
Report Number9615742-2021-00343
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 02/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM9
Device Catalogue NumberSYM9
Device LOT NumberPSC1154X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/07/2018
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: 02/12/2021 Patient Sequence Number: 1
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