MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; CLASS I DEVICE - EXEMPT

Model Number RS22

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a wound closure procedure on (b)(6) 2022 and suture tape was used.The problem of pulling off suture needle happened in surgery.No adverse patient consequences were reported.No additional information was provided.

Manufacturer Narrative

Product complaint #: (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.(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.Additional information was requested and the following was obtained: was there any adverse consequence associated with the patient? no.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16042781
• MDR Text Key: 307794584
• Report Number: 2210968-2022-10612
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2022

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: Health Professional
• Device Model Number: RS22
• Device Catalogue Number: RS22
• Device Lot Number: RMBHTH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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