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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 P101015
Device Problem Mechanics Altered (2984)
Patient Problem No Code Available (3191)
Event Date 09/01/2007
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device was implanted in the body and did not function and the patient had to undergo six surgeries but still the problem prevails.
 
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Brand Name
MESH TSL - PERMACOL¿
Type of Device
MESH, 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 Key7822974
MDR Text Key118436913
Report Number9615742-2018-01942
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000115
UDI-Public10884523000115
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP101015
Device Catalogue NumberP101015
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/11/2018
Initial Date FDA Received08/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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