MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKNOWN

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 06/16/2020

Event Type  Injury  

Event Description

It was reported that during treatment the silicone gel sticks to the protective film.The customer was assisted via e-mail with some instructions given.The treatment was discontinued.It is unknown if the patient was injured.

Manufacturer Narrative

The device, used in treatment, has not been returned for evaluation.No further details were supplied, therefore we are unable to establish a relationship between the reported event and the device or determine a root cause on this occasion.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances in the past three years.Our medical investigation reported: per e-mail communication it is unknown if there was any patient harm that occurred due to the reported issue, without this requested information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A risk management review found the file contains the failure mode of the dressing not adhering / falling off and subsequent harms related to this failure mode.A review of the ifu for flexi-fix products, advises on the storage of these products, as noted temperature fluctuation can affect the silicone.The wound contact surface is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKNOWN OPSITE
• 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
• MDR Report Key: 10245893
• MDR Text Key: 197969402
• Report Number: 8043484-2020-01763
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 1332771848
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention