MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. CUTICERIN 7.5X7.5CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number	66045562
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product is missing the expiration date and lot number, the part where this information normally is, is blank.No patient involved.
Additional Manufacturer Narrative
The device, intended to be used in treatment, has been returned and evaluated.The returned carton confirmed that the expiration and lot details were missing, establishing a relationship with the reported event.The root cause remains undetermined.Further information requests for the lot number, contained on the inner pouches was not provided.Probable cause includes missed quality check, or a packaging printing error.A review of the associated batch manufacturing records could not be carried out as no batch/lot number was provided.A complaint history review found this to be an isolated event, at this time no further action is required.Smith + nephew will continue to monitor for any adverse trends relating to the reported allegation.

• Brand Name: CUTICERIN 7.5X7.5CM CTN 10
• Common Device Name: 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
• MDR Report Key: 10810312
• Report Number: 8043484-2020-03787
• Device Sequence Number: 4011820
• Product Code: KGX
• UDI-Device Identifier: 05000223450182
• UDI-Public: 05000223450182
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66045562
• Device Catalogue Number: 66045562
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1