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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SMPL-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: tecr1515 parietex rigid py 15x15cm x1, lot number: srf1106x. 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 inguinal hernia. It was reported that after implant, the patient experienced mesh infection, inflammatory reaction to mesh, abscess, draining wound, fistulous tract extending to mesh, and granuloma. Post-operative patient treatment included wound vac placement and revision surgery.

 
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Brand NameSURGIPRO
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 Key12318382
MDR Text Key266394554
Report Number9615742-2021-01916
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK982575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSMPL-01
Device Catalogue NumberSMPL-01
Device LOT NumberA8F0550X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/15/2018
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: 08/13/2021 Patient Sequence Number: 1
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