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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); Erythema (1840); Fever (1858); Unspecified Infection (1930); Injury (2348); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a ventral hernia.It was reported that after implant, the patient experienced infection, fever, leukocytosis, erythema, purulent material, and abscess.Post-operative patient treatment included revision surgery, opening of recent wound and drainage of abscess.
 
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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 Key9890019
Report Number9615742-2020-00725
Device Sequence Number19650317
Product Code FTM
UDI-Device Identifier10884523000207
UDI-Public10884523000207
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K120605
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/27/2020
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 Date10/31/2012
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number09B1909
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2020
Initial Report FDA Received Date03/27/2020
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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