MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 AVITENE ULTRAFOAM; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	1050050
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, the physician used avitene ultrafoam.It was reported that the product failed to achieve hemostasis effectively in application.
Additional Manufacturer Narrative
As reported, avitene ultrafoam failed to achieve hemostasis.Based on the limited information provided to date, no conclusion can be made as to why hemostasis was not achieved during the procedure with the use of the avitene ultrafoam product.Additional information has been requested.Note, the date of event is considered to be a best estimate as (b)(6) 2023 based on the date of awareness.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.
Event or Problem Description
As reported, during an unknown procedure, the physician used avitene ultrafoam.It was reported that the product failed to achieve hemostasis effectively in application.
Additional Manufacturer Narrative
As reported, avitene ultrafoam failed to achieve hemostasis.Based on the limited information provided to date, no conclusion can be made as to why hemostasis was not achieved during the procedure with the use of the avitene ultrafoam product.Additional information has been requested.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the provided lot number.Review of manufacturing records indicate product was manufactured to specification.Updated fields: b4, d4, g2, g3, g6, e1, h2, h4, h6, h10.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.

• Brand Name: AVITENE ULTRAFOAM
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 17266999
• Report Number: 1213643-2023-00253
• Device Sequence Number: 15431844
• Product Code: LMF
• UDI-Device Identifier: 00801741010552
• UDI-Public: (01)00801741010552
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 08/28/2024
• Device Catalogue Number: 1050050
• Device Lot Number: WBFU0041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown