MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J423H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The surgeon expected time between the suture placement and the "absorption"? which tissue layer, at which location was the suture, was used to close? what medical/surgical intervention was performed for the patient symptoms? patient symptoms manifestations (location, severity, appearance, systemic or local reaction).What is the current status of the patient? what is the name and date of the procedure? event date? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture was not absorbed resulting in suture abscesses.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 8/21/2020.Additional information was requested and the following was obtained: what medical/surgical intervention was performed for the patient symptoms? removed the suture.Patient symptoms manifestations (location, severity, appearance, systemic or local reaction) wound abscess.What is the current status of the patient? patient is fine.The following information was requested but unavailable: the surgeon expected time between the suture placement and the "absorption"? which tissue layer, at which location was the suture, was used to close? what is the name and date of the procedure? event date? 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: VCL CT BRD UD 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10376024
• Report Number: 2210968-2020-05908
• Device Sequence Number: 2567205
• Product Code: GAM
• UDI-Device Identifier: 10705031039759
• UDI-Public: 10705031039759
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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 Expiration Date: 07/31/2022
• Device Model Number: J423H
• Device Catalogue Number: J423H
• Device Lot Number: LJ2255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1