MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J497G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Skin Erosion (2075); Impaired Healing (2378)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information: the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch qgmdxp, mfg.Date 6/11/2020; exp.Date 5/31/2025.Batch qcmmea, mfg.Date 3/27/2020; exp.Date 2/28/2025.A manufacturing record evaluation was performed for the finished device possible lot number qgmdxp /j497g50 and qcmmea /j497g50, and no non-conformances related to the reported complaint condition were identified.Attempts are being 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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.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.For each patient that experienced the reported issues: the patient demographic info: age, gender, weight, bmi at the time of index procedure.Date and name of the surgical procedure.The diagnosis and indication for the index surgical procedure.On what tissue was the suture placed? how was the suture placed, interrupted or continuous? how was the suture tied? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what were the patient¿s current symptoms? what date did the patient present with symptoms (# of post-op days)? was medical intervention or surgical intervention provided to the patient? if yes, please describe.What was the appearance of the suture when the symptoms and/or dehiscence occurred? other relevant patient history, comorbidities, concomitant medications.Which suture and lot number were used on this patient? are unopened samples of the product available for return for evaluation? is a copy of the ¿ literature regarding similar reactions with vicryl sutures in the past¿ available? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? note: events reported via mw# 2210968-2021-00161, 2210968-2021-00162.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.Following the procedure, the patient experienced reaction and dehiscence.The wounds are developing a couple weeks post-op, well after infection would be likely.The physician reported they are seeing more follow ups daily with continued skin break down and non-healing wounds.The physician reported they have done a root cause analysis and cannot find any other possibility for the cause.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: (b)(6) 2021.Additional information: h6.Additional h-3 summary: four pictures were received for evaluation.Upon visual inspection of the pictures, foil packets of product code j494, lot # qgmdxp, and qcmmea could be observed.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.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 Manufacturer Narrative
(b)(4).Date sent to the fda: 2/4/2021.Additional h6 investigation findings code: c22 - procedure related photo review.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.(b)(4).Date sent to the fda: 2/4/2021.Corrected h6 component code: g07002 - device not returned.Corrected h3 investigation summary: four pictures were received for evaluation.Upon visual inspection of the pictures, foil packets of product code j497, lot # qgmdxp, and qcmmea could be observed.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.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.

• Brand Name: VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11142651
• Report Number: 2210968-2021-00163
• Device Sequence Number: 4042500
• Product Code: GAM
• UDI-Device Identifier: 10705031040625
• UDI-Public: 10705031040625
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: J497G
• Device Catalogue Number: J497G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 01/20/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/26/2021; 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention