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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 Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2018
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 laparoscopic left inguinal herniorrhaphy procedure, the mesh was placed through the trocar and would not unfurl properly. The mesh was hydrated, and rolled up for insertion through the trocar. Once it was in the patient, the surgeon had difficulty keeping the mesh laid out and it kept rolling back up. The mesh was removed and replaced with another to complete the case. There was no patient injury.

 
Manufacturer Narrative

Evaluation summary: the sample was returned in its original tray and lid packaging. The reported condition was confirmed. A review of the device history record and visual examination has been performed. No failure or ncr that may relate to the reported conditions have been noted. The root cause could not be determined. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during a robotic laparoscopic left inguinal herniorrhaphy procedure, the mesh was placed through the trocar and would not unfurl properly. Once it was in the patient, the surgeon had difficulty keeping the mesh laid out and it kept rolling back up. The mesh was removed and replaced with another to complete the case. There was no patient injury.

 
Manufacturer Narrative

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 Key7569518
MDR Text Key110084832
Report Number9615742-2018-01229
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2020
Device MODEL NumberLPG1510
Device Catalogue NumberLPG1510
Device LOT NumberPRL1134X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/28/2017
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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