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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL

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SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number UNKNOWN-PERMACOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 08/13/2013
Event Type  Injury  
Manufacturer Narrative
Title failure to obtain microbiological culture and its consequence in a mesh-related infection source bmj case rep, 2013 (1-3). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature, a (b)(6) years old patient had acute cholecystitis, gallstone pancreatitis and cholangitis. Which lead to her having percutaneous biliary drainage followed by an open cholecystectomy procedures. Four months post-operative of the aid surgeries, the patient had developed an incisional hernia which was addressed with subsequent laparoscopic repair using a composite mesh. Patient was presented in the emergency room with signs of abscess with surrounding cellulitis of the abdomen a year after the hernia repair. The mesh was removed and patient was implanted with a biological mesh and was provided with antibiotics tailored to the offending pathogen identified postoperative culture of the infected mesh.
 
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Brand NameMESH TSL - PERMACOL¿
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 Key8733241
MDR Text Key149160561
Report Number9615742-2019-02292
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-PERMACOL
Device Catalogue NumberUNKNOWN-PERMACOL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
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: 06/26/2019 Patient Sequence Number: 1
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