MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	HP0510E
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic case, every time the surgeon placed the device through the trocar, the product pulled apart and the mesh was torn.The patient was alive with no injury.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 7011081
• Report Number: 1219930-2017-08611
• Device Sequence Number: 684468
• Product Code: LMG
• UDI-Device Identifier: 10884521082557
• UDI-Public: 10884521082557
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2018
• Device Model Number: HP0510E
• Device Catalogue Number: HP0510E
• Device Lot Number: N7A0485UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1