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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS CA PERMACOL IMPLANT 5X10X1 X1

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SOFRADIM PRODUCTION SAS CA PERMACOL IMPLANT 5X10X1 X1 Back to Search Results
Model Number C100510
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Autoimmune Reaction (1733); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Perforation (2001); Injury (2348); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); 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 hernia. It was reported that after implant, the patient experienced adhesions, abscess, fistula, small bowel resection, infection, intra-abdominal fluid collection, matted bowel, open draining wound, necrosis, bowel perforation, inflammation, fibrosis, and foreign body giant cell reaction. Post-operative patient treatment included removal surgery.
 
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Brand NameCA PERMACOL IMPLANT 5X10X1 X1
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 Key8290615
MDR Text Key134527539
Report Number9615742-2019-00204
Device Sequence Number1
Product Code FTM
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 Non-Healthcare Professional
Type of Report Initial
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC100510
Device Catalogue NumberC100510
Device Lot Number07B15-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
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: 01/30/2019 Patient Sequence Number: 1
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