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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPL1515
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Post Operative Wound Infection (2446); Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

According to the reporter, after oblique inguinal hernia operation, the patient suffered in wound fester infection. Two days after discharge, swelling of the incision and scrotum was found with pain, local flushing and gradually worsening. The patient was re-hospitalize. A hard mass was found from the lower end of the incision to the scrotum. The puncture extracted the pink turbid exudate. The diagnosis was right inguinal indirect hernia repair after infection, with anti - infection treatment. Local skin flushing and tenderness subsided, but the mass did not shrink significantly. Mr examination revealed soft tissue infection of the wound in the right inguinal region with abscess formation. The strong liquid was extracted the next morning and anti-infection treatment was continued.

 
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Brand NamePARIETENE
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 Key9485167
MDR Text Key177173735
Report Number9615742-2019-03870
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPPL1515
Device Catalogue NumberPPL1515
Device LOT NumberSTA2251X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/29/2019
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: 12/17/2019 Patient Sequence Number: 1
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