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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 SPMM-149
Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Inflammation (1932); Ischemia (1942); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 an incisional hernia. It was reported that after implant, the patient experienced recurrence, bowel obstruction, adhesions, (b)(6), dilated bowel, scarring, edematous/inflammatory tissue, tender, seroma, winkled mesh, ischemia, and fistula. Post-operative patient treatment included revision surgery, admission to hospital, hernia repair with new mesh, lysis of adhesions, removal of mesh, vacuum closure of abdomen, enterotomy repair, removal of wound vac, debridement of skin/subcutaneous tissue, secondary closure of wound, rim of skin incised, and bowel resection.

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10951613
MDR Text Key219865880
Report Number9615742-2020-02771
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 12/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2015
Device MODEL NumberSPMM-149
Device Catalogue NumberSPMM-149
Device LOT NumberA0A0327
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/05/2020 Patient Sequence Number: 1
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