MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 6-0 D/A G-1 PRM; SUTURE, ABSORBABLE, NATURAL

Catalog Number	790G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the following information on the authorization to use or disclose information form attached: your surgeon¿s name, email, phone number, address your signature.Please scan the signed form and email back to ethicon.
Event or Problem Description
It was reported by the patient that they underwent an eye surgery for a detached retina on (b)(6) 2022 and suture was used.The patient stated they felt a poke through the white of the eye in three different areas.The patient later clarified they did not feel a ¿poke¿ in the eye and that the suture actually came through the white of the eye.The patient had surgeries for suture removal in (b)(6) 2023 for one suture and an additional 3 sutures in (b)(6) 2024 came through in the form of cysts.The patient started oxervate on (b)(6) for pain.The patient stated that this has been ongoing for three years and had 30 additional doctors trying to figure it out.The patient¿s opinion was that the suture did not dissolve the way it was supposed to.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 information was requested, and the following was obtained: so, i have my surgeons report in front of me and the operation they used two out of the three sutures.Suture chronic gut 6¿0 g ¿ 1 790 g.Suture ethibond 2¿0 ties 185h.And the third one is on my report, but the doctor said he didn¿t use it even though it¿s on my report he said it was opened, but he didn¿t use it and that would be.Suture ethelon 5¿0 rd-one 749g.

• Brand Name: GUT CHR UD 18IN 6-0 D/A G-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22923490
• Report Number: 2210968-2025-09986
• Device Sequence Number: 9144355
• Product Code: GAL
• UDI-Device Identifier: 10705031011670
• UDI-Public: 10705031011670
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 790G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown