MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES SURGIFOAM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	1975
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: what is the lot no.? the lot # is 283851 are any photos available? yes please clarify if the hair was short or long? the hair is short what color was the hair? the hair appears to be black was the product used on the patient? the product was not used on the patien was the surgery delayed because of the malfunction? if yes, how many minutes? surgery was slightly delayed by about 1 1/2 minutes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty procedure on an unknown date and absorbable gelatin was used.The device was opened for a case and the surgical tech noticed that there was a hair on the absorbable gelatin pad.The absorbable gelatin was passed off the field and did not come in contact with the patient or the back table.They opened a new 1975 absorbable gelatin pad to replace the one with the hair on it.No delay or patient harm was reported.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGIFOAM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES; 1000 route 202; raritan NJ 08869
• MDR Report Key: 25410544
• Report Number: 2210968-2026-100014
• Device Sequence Number: 10445229
• Product Code: LMF
• UDI-Device Identifier: 15712123000202
• UDI-Public: 15712123000202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: 1975
• Device Lot Number: 283851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/15/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown