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

Model Number LPG1510AL

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/24/2019

Event Type  malfunction  

Event Description

The mesh tore as the team took the product out of the packaging.

• Brand Name: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8896359
• MDR Text Key: 154408961
• Report Number: 8896359
• Device Sequence Number: 1
• Product Code: FTL
• 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: 07/30/2019,07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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: PSJ0664X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 91