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

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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.What was the initial procedure? when did the issue occurred? what is the product code? what is the lot number? could you please provide us a photo for analysis? what is meant by ¿help to identify the authenticity of the products.¿ if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that it was found there was no chinese label in some absorbable suture, both for outer box and single package.It was requested to authenticate the product identity.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/13/2020.Additional information was requested and the following was obtained: what is meant by ¿help to identify the authenticity of the products.¿ whether they are qualified devices from j&j.The following information was requested but unavailable: what was the initial procedure? when did the issue occurred? what is the product code? what is the lot number? could you please provide us a photo for analysis? 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.Is product involved available for return for further evaluation? is any additional information available that could assist with complaint investigation? 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.

• Brand Name: UNK_SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10643882
• MDR Text Key: 210390243
• Report Number: 2210968-2020-07744
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Patient Sequence Number: 1