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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 UNK PARIET PROGRIP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Injury (2348)
Event Date 03/05/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Phone number unknown. Patient information not provided. Implant and explant date were not provided. Lot number not provided. Udi not provided. Re-processing information not provided. Date received by mfr: since the lot number was not provided, this information cannot be determined. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter: the patient had left inguinal hernia surgery. The patient experienced increased pain after the surgery. The patient had cryo-ablation to dead the nerves to help with the pain. The patient needed to continue to have injections as needed to help with the pain.

 
Manufacturer Narrative

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

 
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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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6432373
MDR Text Key70806491
Report Number9615742-2017-05053
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK PARIET PROGRIP
Device Catalogue NumberUNK PARIET PROGRIP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/24/2017 Patient Sequence Number: 1
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