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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: the visual examination of the sample shows that the sample was placed in a biohazard bag. The sample was returned in its original aluminum pouch, blister and tyvek. The temperature dot was white and the mesh was found contaminated by blood. The mesh was found folded in both corners at the other edge of the flap and the dimensions 15x10 are found as expected. The mesh was found torn along the sewing between the flap and the mesh. The hole is around 5 x 1 cm. The reported condition was confirmed. Excessive manipulation by the user is highly suspected. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, during a robotic laparoscopic inguinal hernia procedure (robot tapp) using a 10mm trocar. When using graspers to unfurl the mesh, a hole was easily created in the mesh during placement. To resolve the issue the damaged mesh was removed and replaced with a new piece of mesh. There was no injury as a result of the event. The patient status is alive with no injury. The mesh was not cut prior to the procedure. The mesh was not folded at the 2 violet expanders. The mesh was hydrated prior to use. There was no issue with the packaging. The current patient status is fine.
 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6646911
MDR Text Key119406439
Report Number9615742-2017-05162
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device Lot NumberPRC0354X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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