MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y936H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Was there any additional tissue damage as a result of searching for the needle? was there any additional post op patient care required as a result? was there any adverse patient outcome?.

Event Description

It was reported that the patient underwent a caesarean procedure on an (b)(6) 2018 and suture was used.During subcutaneous closure the needle detached from the thread.During closure in the subcutaneous-aponeurosis they searched for the needle and could not find it.The thread did not appear after cleaning the room and reviewing the material.After a careful and exhaustive revision, the subcutaneous and skin were closed.An x-ray of the abdominal wall was absent of radiopaque images suggestive of metallic material.The patient was informed.There was no adverse patient outcome.Additional information has been requested.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 3-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. BRAZIL; rodovia presidente dutra,; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7509183
• MDR Text Key: 108162807
• Report Number: 2210968-2018-72773
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: 10705031059917
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: Y936H
• Device Lot Number: AK1916
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/11/2018
• Date Device Manufactured: 01/22/2018
• 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