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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 Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when the surgeon unrolled the mesh on left inguinal during a robotic transabdominal pre-peritoneal (tapp) bilateral inguinal hernia repair, a split was evident along the seam of the mesh. The defect was about 2cm. They used suture to approximate the seam and complete the implantation of the mesh. They took approximately 5-10 minutes to sew the mesh defect together. There was no patient injury.
 
Manufacturer Narrative
Evaluation summary: one device was returned for investigation. A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted. The visual examination of the 3 provided pictures show that: the sample was placed into the abdominal wall. A needle was on the right of the picture and near the mesh. A hole of around 12 stitches was visible. The quality of the picture does not allow us to confirm where exactly is located the hole in the mesh, the textile knitting pattern, the collagen film and the sewing. The reported condition was confirmed. It should be noted that the mesh was placed with a robotic-assisted tapp to repair bilateral inguinal hernia repair. A search of our global complaints database revealed that this was the only report on file for this lot of product. The report has been added to our product complaints database which is monitored for similar occurrences. 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. Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis. If additional information is obtained, or the sample is returned, we will re-open this investigation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when the surgeon unrolled the mesh on left inguinal during a robotic transabdominal pre-peritoneal (tapp) bilateral inguinal hernia repair, a split was evident along the seam of the mesh. The defect was about 2cm. They used suture to approximate the seam and complete the implantation of the mesh. They took approximately 5-10 minutes to sew the mesh defect together. 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 Key8084629
MDR Text Key127618511
Report Number9615742-2018-02581
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
Type of Report Initial,Followup
Report Date 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberPRL1191X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2018
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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