MAUDE Adverse Event Report: ETHICON INC. MONOCRYL* UD MONO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y423H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Ulcer (2274); Impaired Healing (2378)

Event Date 10/01/2022

Event Type  Injury  

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.(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 a prescription for steroids or antibiotics necessary for the recovery of the patients? if yes, could you provide us with the name, route and dose of the drug? yes, but we don't have more information.- what is the current condition of the patients? we do not know.- could you provide us with the dates of the proceedings? between october 1 and 27, 2022.Related medwatch reports: 2210968-2022-10273.

Event Description

It was reported that a patient underwent a breast surgery in (b)(6) 2022 and suture was used.The patient presented with immediate post-operative inflammatory plaques on the skin with healing difficulties, especially at the level of the suture knots.The patient developed ulcerations and was treated with picotherapy (tpn).Additional information was requested.

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 followup report will be filed as appropriate.Additional information was requested, and the following was obtained: what is the indication for the initial surgery? we don't have the answer.What was the approach (open, laparoscopic or other)? we don't have the answer.What tissue was the suture used on? skin.What was the condition of the tissues (normal, fine, calcified, fragile, diseased)? normal.How was the suture placed (interrupted or continuous)? we don't have the answer.How was the suture originally tied (multiple knots, square knot, etc.)? we don't have the answer.Did you observe a defect or anomaly of the sutures before, during, after the placement of the sutures or during a reoperation? nope.Could you describe the manifestations in the patient (location, severity, appearance, systemic or local reaction).Start date ? location: at the suture knots.High severity because a patient ended up in the hyperbaric chamber, appearance of inflammatory plaques, blisters and budding, ulcerations.Have any preoperative cleaning procedures or products changed recently? we don't have the answer.Does the patient have a known allergic history to medical devices, foods and/or drugs? we don't have the answer.Were there any preexisting signs/symptoms of active inflammation/infection prior to this surgery? we don't have the answer.Were cultures carried out? results? we don't have the answer.What is the physician's opinion of the etiology or contributing factors to this event? etiology: monocryl threads, because it happened on 2 batches, to 3 different doctors.When quarantining batches, no more such statements.What is the current condition of the patient? we don't have the answer.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 initial information reported the 2 sutures involved in the event were: monocryl suture product code y423h, lot sgmbut.Monocryl suture product code y423h, lot shmsdc.Upon investigation it was determined that: lot sgmbut is related to product code 661g12, ethilon suture.Lot shmsdc is related to product code sxpp1a40112, stratafix symmetric pds plus.For each device, please provide the following: name/type of suture? product code? lot number?.

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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Type of Device: 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 ; 9083863534
• MDR Report Key: 15984153
• MDR Text Key: 305490109
• Report Number: 2210968-2022-10274
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: Y423H
• Device Lot Number: SHMSQC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention