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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 Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received. The device was not returned, but a photo was available for evaluation. Visual inspection noted that the product was used outside the instructions for use (ifu) specifications. It was reported that the mesh was difficult to adhere, did not stay in place, or shifted within the patient while being implanted. The reported issue was confirmed. The product analysis noted evidence that the device was not used as intended. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. A secondary review of the device history records found no potentially contributing factors. The instructions included with this device provide the following guidance: progrip¿ laparoscopic self-fixating mesh needs to be hydrated for a few seconds in a sterile saline solution before use. Rolling/folding of the mesh: a. For the rectangular mesh, it is recommended to roll the mesh in the length-wise direction. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during robotic laparoscopic inguinal hernia repair, the mesh was not adhering/sticking as it should. A suture was used to keep it in place before closing the peritoneal space. There was no patient injury.
 
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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 Key11189705
MDR Text Key227489913
Report Number9615742-2021-00160
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510
Device Catalogue NumberLPG1510
Device Lot NumberPUF0774X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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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