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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 LPG1510
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2018
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 inguinal hernia repair, 2 pieces of mesh were damaged. These were not used in the patient. Replaced by new device to complete the case. There was no injury.
 
Manufacturer Narrative
Evaluation summary: one device was returned. A review of the device history record has been performed by trevoux quality assurance. No failure or ncr that may relate to the reported conditions have been noted. The visual examination of the returned sample shows that: the sample was returned in its original package (commercial box and aluminum pouch). The textile knitting pattern, the mesh dimension and the collagen film were found as expected. Few traces were drawn on the mesh. The mesh has not been cut. The reported condition was not confirmed. It should be noted that the mesh was placed with a robotic-assistance to repair inguinal hernia. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. The reported condition was not confirmed by the returned sample. 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 Key7943204
MDR Text Key123371728
Report Number9615742-2018-02252
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 12/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberLPG1510
Device Catalogue NumberLPG1510
Device Lot NumberPSC0600X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
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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