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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PROGRIP
Device Problem Obstruction of Flow (2423)
Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4) (laparotomy) if information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post laparoscopic ventral hernia repair, the patient had a bowel obstruction from the two devices used. The patient was brought back to the operating room and laparotomy was performed. The event leads to extend patient hospitalization.

 
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Brand NameUNKNOWN 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 Key7949112
MDR Text Key123146980
Report Number9615742-2018-02256
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX PROGRIP
Device Catalogue NumberUNKNOWN PARIETEX PROGRIP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
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: 10/09/2018 Patient Sequence Number: 1
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