MAUDE Adverse Event Report: DAVOL INC. - 1223089 AVITENE WEB SHEETS; AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual evaluation of the subject product was performed.A fiber was found caught between the lid and inner tray as was reported.The integrity of the seal of the inner tray holding the product had not been compromised.The fiber could not be readily identified by visual characteristics.Root cause is identified as manufacturing related, as the fiber would have been introduced at the time of packaging.This is the first report of a foreign material for the subject lot of (b)(4) units manufactured in june of 2018.
Event or Problem Description
It was reported that a fiber was caught between the tyvek lid and the tray of the avitene product package.This was noted prior to use in the case.The device was returned for evaluation.

• Brand Name: AVITENE WEB SHEETS
• Common Device Name: AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC. - 1223089; 160 new boston street; woburn MA 01801
• MDR Report Key: 8843535
• Report Number: 1213643-2019-06453
• Device Sequence Number: 10835278
• Product Code: LMF
• UDI-Device Identifier: 00801741010460
• UDI-Public: (01)00801741010460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P800002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 05/28/2022
• Device Catalogue Number: 1010250
• Device Lot Number: WBCS0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1