MAUDE Adverse Event Report: ETHICON INC. MERSILENE* GRN 3-0 15X45CM N/N; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number SMV73T

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.

Event Description

It was reported that when storing the suture, we noticed that 1 unit came with a hole in the packaging.No adverse patient consequences were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/13/2020.A manufacturing record evaluation was performed for the finished device lot number an0806, and no non conformances / manufacturing irregularities were identified.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.

• Type of Device: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10509889
• MDR Text Key: 206330083
• Report Number: 2210968-2020-06743
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMV73T
• Device Lot Number: AN0806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Patient Sequence Number: 1