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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 SYM12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scarring (2061); Seroma (2069); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(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 incisional hernia. It was reported that after the underlay implant, the patient experienced infected mesh, abscess, seroma, necrosis, adhesions, scarring, sinus tract, infection, nausea, chills, inflammation, recurrence, pain, fluid collection, discharge, lower half of umbilicus was dehisced, erythema, open wound and suffering. Post-operative patient treatment included revision surgery, removal of mesh, umbilicus resected, incision/drainage of abdomen, excisional debridement of skin/subcutaneous tissue, complex closure of wound, drain removed prematurely, abdominoplasty, abdominal washout, excision of sinus tract, incision/drainage of abscess, abdominal wall reconstruction, and drain placement.

 
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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 Key10200955
MDR Text Key196621691
Report Number9615742-2020-01363
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,Followup
Report Date 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device MODEL NumberSYM12
Device Catalogue NumberSYM12
Device LOT NumberPPH0055X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/08/2015
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: 06/26/2020 Patient Sequence Number: 1
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