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

Model Number	HP0510E
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: when the packaging of the product was opened, the patches were always broken in small pieces when trying to roll it.The material is not flexible enough.The issue occurred prior to use.There was no patient involvement.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7085243
• Report Number: 1219930-2017-09440
• Device Sequence Number: 1495426
• Product Code: LMG
• UDI-Device Identifier: 20884521082554
• UDI-Public: 20884521082554
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 06/02/2018
• Device Model Number: HP0510E
• Device Catalogue Number: HP0510E
• Device Lot Number: N7F0068UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1