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

Catalog Number	1050030
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The outer packaging was intact, and the inner packaging was completely sealed before opening.The ultrafoam was not used and there was no patient injury.
Additional Manufacturer Narrative
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The mesh is being returned for evaluation but has not yet been received.Photos and video provided confirming, there is a small area of discoloration (brown in color) present on the ultrafoam.Photos/video do not assist in determining root cause.Based on the information provided and not having the physical sample to evaluate at this time no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.
Additional Manufacturer Narrative
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The mesh is being returned for evaluation but has not yet been received.Photos and video provided confirming, there is a small area of discoloration (brown in color) present on the ultrafoam.Photos/video do not assist in determining root cause.Based on the information provided and not having the physical sample to evaluate at this time no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Visual inspection identified two embedded foreign materials in the finished product brown in color.As it could not be determined whether the material was true foreign contamination or discolored flour, the sample was sent for further identification testing.The sample underwent optical microscopy (om) and imaging micro-fourier transform infrared spectroscopy (iftir) at an external laboratory.Testing confirmed that the brown fragments were chitin, exhibiting morphology consistent with insect fragments.Based on the investigational actives performed the fragments are found to have presented at some point during the manufacturing process.When or how during the process the fragments presented cannot be determined at this time.Actions are being taken to further investigate.Updated fields: b4, d9, g3, g6, h2, h3, 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.
Event or Problem Description
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The outer packaging was intact, and the inner packaging was completely sealed before opening.The ultrafoam was not used and there was no patient injury.
Event or Problem Description
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The outer packaging was intact, and the inner packaging was completely sealed before opening.The ultrafoam was not used and there was no patient injury.
Additional Manufacturer Narrative
As reported, an avitene ultrafoam allegedly had a foreign material (small brown color) on the surface of the product in the inner sterile package; discovered prior to use.The mesh is being returned for evaluation but has not yet been received.Photos and video provided confirming, there is a small area of discoloration (brown in color) present on the ultrafoam.Photos/video do not assist in determining root cause.Based on the information provided and not having the physical sample to evaluate at this time no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum 1: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Visual inspection identified two embedded foreign materials in the finished product brown in color.As it could not be determined whether the material was true foreign contamination or discolored flour, the sample was sent for further identification testing.The sample underwent optical microscopy (om) and imaging micro-fourier transform infrared spectroscopy (iftir) at an external laboratory.Testing confirmed that the brown fragments were chitin, exhibiting morphology consistent with insect fragments.Based on the investigational actives performed the fragments are found to have presented at some point during the manufacturing process.When or how during the process the fragments presented cannot be determined at this time.Actions are being taken to further investigate.Addendum 2: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the field action that was undertaken and reported to fda.Ref.Field action report number 1213643-03/13/2026-001-c.The action is still under review for recall classification and fda has not completed classification.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.

• 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: 23829294
• Report Number: 1213643-2025-01234
• Device Sequence Number: 9268354
• Product Code: LMF
• UDI-Device Identifier: 10801741010535
• UDI-Public: (01)10801741010535(17)270728(10)WBJS0055
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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 Catalogue Number: 1050030
• Device Lot Number: WBJS0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 03/13/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/04/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1213643-03/13/2026-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown