MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. CADEX OINTMENT PACK 3 X 17G; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800055

Device Problems Delivered as Unsterile Product (1421); Material Split, Cut or Torn (4008)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

Internal reference number (b)(4).

Event Description

It was reported that, when two (2) pouches of cadex ointment pack 3 x 17g were taken out the carton, it was noticed that the pouches were torn and with a small amount of ointment leakage.Sterility could be compromised.They were found when incoming products were checked at an on-site hospital, so patient or treatment was not involved.

• Brand Name: CADEX OINTMENT PACK 3 X 17G
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17159066
• MDR Text Key: 318102474
• Report Number: 8043484-2023-00038
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223466589
• UDI-Public: 5000223466589
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2023

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 Catalogue Number: 66800055
• Device Lot Number: CFC182
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1