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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1515G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Nausea (1970); Seroma (2069); Chills (2191); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 04/13/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post operatively, on an incarcerated incisional herniorrhaphy with the mesh, the seroma opened up and started draining serosanguinous fluid, no purulence. Dressing was placed and the patient was instructed to change the dressing when saturated or at least every day. The seroma re-appeared and the patient had fever, chills and nausea. Irrigation, debridement, antibiotics and wound vacuum-assisted closure was placed at bedside. The mesh caused an infection and was removed. Additional surgical procedures of irrigation and debridement of the abdominal wound were performed.

 
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Brand NameMESH SOFRADIM - PARIETEX¿ PROGRIP¿
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 Key8706089
MDR Text Key148255491
Report Number9615742-2019-02211
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 06/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTEM1515G
Device Catalogue NumberTEM1515G
Device LOT NumberSRK0451X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/14/2017
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: 06/17/2019 Patient Sequence Number: 1
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