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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1510AR
Device Problem Device Sensing Problem (2917)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, on a laparoscopic inguinal hernia repair, after the mesh was implanted, prior to closing, it was found that the temperature gauge on the mesh had turned black. The mesh was explanted and added about an hour to the procedure. Another device was used to complete the case.
 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key10506820
MDR Text Key206091607
Report Number9615742-2020-01975
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device Lot NumberPUB1415X
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 Received09/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/26/2020
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: 09/09/2020 Patient Sequence Number: 1
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