MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4007
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that when the release paper #1 was removed, the film was lifted and creased, so it could not be used.Several dressings in the carton were checked and all were affected.Competitive products were used for the treatment.No delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The clinical evaluation concluded: a review of this complaint case revealed there were no patient injuries reported.Per e-mail communication the dressing was not used on the patient.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The associated risk files contain the reported failure/harm or event.However, the clinical review has not established a causal link.Additional rmr is not required.The device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.A visual inspection confirmed the crease reported.The root cause has been determined as a maintenance related issue, now resolved.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, complaint history file contains further instances.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• 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: 11364880
• Report Number: 8043484-2021-00381
• Device Sequence Number: 11024509
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4007
• Device Lot Number: 201941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1