MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1961
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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? white things the following information was requested, but unavailable: what was the texture? unk is it possible that the foreign material fell into packaging upon opening of device? unk was the product seal on the foil still intact when the package was opened? unk.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 tooth extraction procedure on (b)(6) 2025 and absorbable hemostat was used.During a tooth extraction at the outpatient/treatment room, when opening the package, it was not in the expected condition, so the product was not used, and another package was opened and used instead.There were no abnormalities in the package from the same lot (the package in the same box) used as a replacement for the product involved.On (b)(6), the product was retrieved after the customer requested a return/exchange due to solid matter that is not cotton.The condition of the product from the previous day, the product had been torn into pieces for easier use after opening the package.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: h 3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h3 investigation summary according to information received, it was reported foreign matter inside sterile barrier.The product was returned to ethicon for evaluation.One empty pouch and one empty folder packet that pertains to product code 1961 was received for analysis.The visual assessment of the product noted that the oxidized regenerated cellulose was not returned for evaluation.However, a photo was provided showing one piece of oxidized regenerated with incomplete carding.Based on the photo received, it is not possible to definitively determine the root cause of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected investigation summary = > according to information received, it was reported foreign matter inside sterile barrier.The product was returned to ethicon for evaluation.One empty pouch and one empty folder packet that pertains to product code 1961 was received for analysis.The visual assessment of the product noted that the oxidized regenerated cellulose was not returned for evaluation.Five photos were provided showing the following: in three photos it was observed one piece of oxidized regenerated with incomplete carding; while the other two remaining photos was noted one pouch for product code 1961 and opposited side with lot number 107559.Based on the photos received, it is not possible to definitively determine the root cause of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - pending evaluation of returned device.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.

• Brand Name: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23316519
• Report Number: 2210968-2025-11967
• Device Sequence Number: 5815087
• Product Code: LMG
• UDI-Device Identifier: 10705031003118
• UDI-Public: (01)10705031003118(17)271231(10)107559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/20/2025

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: 1961
• Device Lot Number: 107559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 11/06/2025; 11/13/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/03/2025; 11/11/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sex: Unknown