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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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.Are all these three sutures (suture unknown, suture unknown and vicryl suture ) broke on cat #1 ( kika)? product codes and lot numbers for two suture unknown? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events sent via 2210968-2020-05556, 2210968-2020-05557 and 2210968-2020-05558.

Event Description

It was reported that the cat underwent a spay procedure on (b)(6) 2020 and the suture was used on one of three layers.It was reported that a day after, the suture snapped in several places post-op.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 8/13/2020.Corrected information: b1, h1 ¿ it was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.Additional information was requested and the following was obtained: yes only one suture broke in each case.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.Event reported via 2210968-2020-05558.

• Brand Name: 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: 10321695
• MDR Text Key: 200283525
• Report Number: 2210968-2020-05556
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1