MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number SUTUREUNK

Device Problem Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Pocket Erosion (2013); Skin Inflammation/ Irritation (4545)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

(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.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 following information was requested, but unavailable: did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.There was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.What is the lot number & product code?.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, one week after discharge, the patient was rechecked.The wound was slightly red, and it was visible that some of the suture did not fall off and absorb.The remaining suture was immediately disinfected and removed, and the wound was instructed to keep dry and clean.Three days later, the wound was rechecked without redness, swelling, pain, and healed well.Additional information was requested.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15974576
• MDR Text Key: 308298228
• Report Number: 2210968-2022-10231
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SUTUREUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 37 YR
• Patient Sex: Female