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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 SYM2015OS
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Erythema (1840); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Pain (1994); Seroma (2069); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); 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 therapeutic treatment of a hernia. It was reported that after implant, the patient experienced mesh migration, infection, adhesions, abscess, and draining wound. Post-operative patient treatment included bowel resection and revision 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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12686961
MDR Text Key278078695
Report Number9615742-2021-02344
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberSYM2015OS
Device Catalogue NumberSYM2015OS
Device Lot NumberPOE0520X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/05/2014
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: 10/24/2021 Patient Sequence Number: 1
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