MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN 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	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: when the packaging for the patch was opened, the patch was cracking between the fingers of the nurse when taking it out.It was very dry and broke into pieces before it could be laid down.The case was completed using a new patch.

• 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: 7004572
• Report Number: 1219930-2017-08566
• Device Sequence Number: 1496632
• Product Code: LMG
• UDI-Device Identifier: 10884521082557
• UDI-Public: 10884521082557
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 11/06/2017

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: 05/19/2018
• Device Model Number: HP0510E
• Device Catalogue Number: HP0510E
• Device Lot Number: N7E0731UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1