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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 P152840
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930); Necrosis (1971); Ulceration (2116); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, open wound, infection, and abscess. Post-operative patient treatment included revision surgery.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
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 Key9456899
MDR Text Key170415832
Report Number9615742-2019-03831
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2014
Device Model NumberP152840
Device Catalogue NumberP152840
Device Lot Number10B2302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
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: 12/12/2019 Patient Sequence Number: 1
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