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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP PROGRIP MESH, SURGICAL, POLYMERIC

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COVIDIEN LP PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1510AR
Device Problems Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 07/30/2020
Event Type  Malfunction  
Event Description

Reporter states "we were using the covidien progrip laparoscopic self fixating mesh. We placed in the abdomen and unrolled it. The graph tore and we had to cut to remove. Exp date 11/30/2022. This isn't the first time the covidien progrip has torn. " procedural description: "once we had completely cleared the hernia defect i chose a standard progrip mesh for the right side. The mesh was advanced into the abdomen and placed over the hernia defect with good approximation and overlap on all sides. The mesh then tore at the seam where the flap attaches to the main mesh. The mesh was cut into three pieces and removed. A new mesh was applied and was secure without defect. The peritoneal flap was then reapproximated using a strata fix suture which completely cover the mesh. We performed the same dissection on the left side. I then placed a left side mesh on the opposite side in the same fashion with good coverage over the direct, indirect, and femoral spaces. The peritonial flap was reapproximated with stratafix as well. " "new mesh applied and was secure without defect" was same model (lpg1510ar) & lot (ptl1016x) # as the mesh that tore. Also successfully implanted was a covidien progrip laparoscopic self fixating mesh 10 x 15, lpg1510al, lot # ptk2048x.

 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key10448164
MDR Text Key204202855
Report Number10448164
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device LOT NumberPTL1016X
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2020
Event Location Hospital
Date Report TO Manufacturer08/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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