MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 10CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000041
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, the opsite film is rolled too tightly, and it can't be unrolled properly.Sometimes it sticks to the inside of the box and the packaging has to be disposed of.The procedure was successfully completed without significant delay using a competitor device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: the device, used in treatment, has not been returned for evaluation.The supplied images and further information have been reviewed establishing a relationship between the device and the reported event, however the root cause remains unknown.The image confirms, sections of the cardboard are adhered to the side of the dressing role, which would make the roll difficult to unroll during use.A probable root cause may include, storage and temperature fluctuation, resulting in adhesive causing the bandage to stick to the inside of the box.A medical review concluded, no further action deemed necessary.No batch/lot number has been provided, therefore a review of the device history has not been possible.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm, however as no harm alleged, additional review is not required.The complaint history file contains further instances.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE FLEXIFIX 10CMX10M CTN 1
• 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: 11197619
• Report Number: 8043484-2021-00140
• Device Sequence Number: 18993194
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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): 11/03/2021

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: 66000041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention