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

Model Number LPG1510AL

Device Problems Material Puncture/Hole (1504); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

A 15 x 10 cm piece of parietex progrip mesh that was anatomically shaped was folded, marked, moistened and inserted.It was then deployed, centering it on the hernia defect.We noted a hole in the mid portion of the mesh at the seam.The mesh was removed and held.A new piece was opened and placed in the same manner.The mesh laid nicely in place.

• Brand Name: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8260423
• MDR Text Key: 133528555
• Report Number: 8260423
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513174
• UDI-Public: (01)10884521513174(17)201031(10)PRK1463X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: PRK1463X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Weight: 79