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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PERMACOL; MESH, SURGICAL
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SOFRADIM PRODUCTION SAS PERMACOL; MESH, SURGICAL Back to Search Results
Model Number P152030
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abscess (1690); Foreign Body Reaction (1868); Pain (1994); Hernia (2240); Discomfort (2330); Ascites (2596); Unspecified Tissue Injury (4559)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal hernia.It was reported that after implant, the patient experienced hernia recurrence, foreign body reaction, abscess, fluid collection, severe and chronic pain and discomfort.Post-operative patient treatment included revision surgery and abdominal wall reconstruction,.
 
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Brand Name
PERMACOL
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key12173808
Report Number9615742-2021-01706
Device Sequence Number924990
Product Code FTM
UDI-Device Identifier10884523000207
UDI-Public10884523000207
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K120605
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2019
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot NumberAOK0588
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2021
Initial Report FDA Received Date07/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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