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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 LPG1510AL
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a robotic laparoscopy while doing inguinal hernia repair, toward the end of the procedure when the mesh was implanted, as the surgeon was unfolding the mesh, it tore at the seam. The mesh was not cut prior to implantation, the wound was closed after the procedure by suture and the mesh was damaged. The torn mesh was removed and a new piece of mesh was implanted to complete the case. There was no patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance led an evaluation of one device. The visual examination of the returned sample shows that the sample was not returned in its original packaging. The mesh was placed in its blister and a part of its aluminum pouch. The mesh was found contaminated by blood. The mesh has been cut. The textile knitting and collagen part were found as expected. A hole is visible along the sewing between both parts of the mesh. The reported condition was confirmed. Excessive tension is highly suspected. The product ifu (instructions for use) which accompanies each device states: ¿warnings and precautions¿ that: if an anatomical mesh is re-cut, special care should be taken to preserve the sewing to limit the risk of recurrence. Excessive tension potentially increase by the cut of the mesh may have been applied. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7351952
MDR Text Key102850570
Report Number9615742-2018-00558
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberPRF0382X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2017
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: 03/20/2018 Patient Sequence Number: 1
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