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

Model Number	HP0204E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, prior use, the device broken.There was no patient involved in this event.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.Two of the patches were received undamaged and in good condition remaining pliable and not falling apart when manipulated.The third patch was received with the packaging opened and the patch was crumbling and cracking.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.A possible root cause is improper storage of the product but there is no reliable way to determine when the product was improperly stored.No enhancements or improvements were generated for the reported condition.A review of the current complaint data reveals no trend for a device related failure for this condition.The reported condition was not confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6493076
• Report Number: 1219930-2017-05289
• Device Sequence Number: 1331403
• Product Code: LMG
• UDI-Device Identifier: 10884521082533
• UDI-Public: 10884521082533
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 07/24/2017

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: 11/29/2017
• Device Model Number: HP0204E
• Device Catalogue Number: HP0204E
• Device Lot Number: N6L0893UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1