MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J496G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pocket Erosion (2013); Skin Inflammation/ Irritation (4545)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
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: was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.If yes,- medical (drainage and culture).Was the suture trimmed in physician¿s office? was the suture removed in a routine post-op procedure? yes.Was the suture removed in a reoperation procedure? yes.Was reoperation necessary to remove the suture and re-close the wound? no.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.Kenalog.What is the patient¿s current status? healing.Did the operating surgeon observe any suture deficiency or anomaly before or during the suture placement? no.What was the name of the procedure? excision.What was the procedure date? jan 5,2022 - feb 2022.Please confirm which lot number (rjmcxx or rhmezt) is involved for each patient? only used 1 suture on patient.Lot number was rjmcxx.Device history lot: a manufacturing record evaluation was performed for the finished device rjmcxx/ j496g50 batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient that had the covid vaccine experienced a reaction like dermatitis because the suture was not dissolving.The hcp referred this to a "spitting suture".No hospitalization.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(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.Investigation summary = > the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that four sealed boxes with twelve packets ea.Of product code j496g were received to ethicon inc for evaluation, the samples were examined for visual defects: ¿ appearance ¿ color package ¿ wrinkles in the seal area ¿ continuous seals ¿ seal margins ¿ over-sealing ¿ damage (torn, punctured) packets were opened, and the swage and attachment area was noted to be as expected.During the visual inspection, the sutures were correctly placed on the paper folder.Sutures were dispensed without problems and examined along the strand and no defects, damage on the suture surface could be observed.In addition, the suture retains approximately 75% of the original tensile strength at two weeks post-implantation.At three weeks, approximately 50% and the absorption total of vicryl suture is essentially complete between 56 and 70 days.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Complaint information will be included in the complaint trending that is reviewed on a regular basis to determine if further action is necessary.,.

• Brand Name: VCL CT BRD UD 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13677364
• Report Number: 2210968-2022-01491
• Device Sequence Number: 5375664
• Product Code: GAM
• UDI-Device Identifier: 10705031040588
• UDI-Public: 10705031040588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Expiration Date: 07/31/2026
• Device Model Number: J496G
• Device Catalogue Number: J496G
• Device Lot Number: RJMCXX
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female