MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW ABS; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	2093
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: no further information is available and no product to return.The following information was requested, but unavailable: what is the lot number? where was the foreign material found? (inside shipping box, inside implant box, directly on device?) are there any photos of the foreign matter available? is it possible that the foreign material fell into packaging upon opening of device? was the product seal still intact when the package was opened? device return status.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 an unknown procedure on an unknown date with absorbable hemostat.A hair was found in the packaging.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGICEL SNOW ABS
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12315277
• Report Number: 2210968-2021-07281
• Device Sequence Number: 3181615
• Product Code: LMG
• UDI-Device Identifier: 10705031063631
• UDI-Public: 10705031063631
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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 Model Number: 2093
• Device Catalogue Number: 2093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1