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

Catalog Number 66000041

Device Problem Nonstandard Device (1420)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  malfunction  

Event Description

It was reported that in opsite flexifix 10cm x 10cm, ctn 1, a discoloration in the protective backing was found, also the tape appears more flimsy and edges curl causing lifting and in both occasions leaking of urostomy.There was no changes in urostomy output, the procedure was successfully completed using the same device.No patient injury, delay or other complications were reported.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been further complaints reported with this failure mode in the past three years.The device was used for treatment.It was reported that the film was curling and lifting.As no samples were returned a thorough product evaluation could not be carried out.Low adhesion may be caused by adhesion levels of the raw material used to make the film.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.We have not been able to confirm a relationship between the event and the device.The root cause remains undetermined.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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

Manufacturer Narrative

Additional information received from reporter has confirmed that the incident reported in this complaint is the same reported under complaint case-2020-00015138-1, with mdr no.8043484-2020-02802.We therefore close this complaint as a duplicate.Further communications and results of investigation will be sent under mdr no.8043484-2020-02802.

• Brand Name: OPSITE FLEXIFIX 10CMX10M CTN 1
• 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: 10511565
• MDR Text Key: 206282203
• Report Number: 8043484-2020-02800
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• 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,Followup
• Report Date: 12/10/2020

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 Operator: Health Professional
• Device Catalogue Number: 66000041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 12/10/2020
• Supplement Dates FDA Received: 10/02/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1