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

Catalog Number	J496H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Erythema (1840); Impaired Healing (2378)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.1.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.2.Was dehiscence noted? 3.What is the most current patient status? 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 a patient underwent a pacemaker pocket closure procedure on an unknown date in 2024 and suture was used.Post op of procedure, patient came in for their six week follow up check the sutures had not yet dissolved.Surgeon keeping a close eye on it to ensure infection does not set in.No product returning.Suture was used on the outer layer of skin with steri strips, gauze and then a tegaderm.Additional information has been 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, 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Additional information was requested, and the following was obtained: ¿ suture removal at 6 week follow up -keflex bid x 7 days.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date of index surgical procedure? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? were the sutures surgically removed or removed during a routine office visit? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? did the patient have an infection? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? (patient 1, 5, 6 & 7 received medication, please clarify if anything additional was given) were cultures performed? if so, please provide the results.Were any pre-op cleansing procedures changed recently? if yes, please describe other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
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, 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 information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.59 y.O female 132 1b bmi @ 22.7.Date of index surgical procedure? (b)(6) 2024.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.How was the suture placed (interrupted or continuous)? unknown.How was the suture originally tied (multiple knots, square knot, etc.)? unknown.Nere the sutures surgically removed or removed during a routine office visit? suture removed on (b)(6) 2024.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unknown.That symptoms did the patient experience following the index surgical procedure? redness/irritation thought.Be from bra strap onset date? reported at 6 week follow up (b)(6) 2024.Did the patient have an infection? treated with prophylactic keflex 500 mg bid x 7 days nere there any pre-existing signs/symptoms of active infection prior to this surgical procedure? on (b)(6) 2024 cbc wnl.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? (patient 1 , 5, 6 & 7 received medication, please clarify if anything additional was given) treated with prophylactic keflex 500 mg bid x 7 lays.Were cultures performed? if so, please provide the results.No were any pre-op cleansing procedures changed recently? if yes, please describe unknown.Other relevant patient history/concomitant medications? nia what is the physician's opinion as to the etiology of or contributing factors to this event? what is the patient's current status? stable/healed incision site surgeon's name? dr.(b)(6).

• 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20265488
• Report Number: 2210968-2024-10083
• Device Sequence Number: 15627188
• Product Code: GAM
• UDI-Device Identifier: 10705031040595
• UDI-Public: (01)10705031040595(17)280731(10)TBBBPRA0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: J496H
• Device Lot Number: TBBBPRA0
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 10/14/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG