MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 10 X8CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800136

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the customer complains that the packaging units are too large.No harm or injury reported and the procedure was completed with a competitor device.

Manufacturer Narrative

Additional information: d4.

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.The complaint history review found no further instances of the reported event.The device was intended for use in treatment.No samples were returned for analysis.The reported issue may be attributed to procedural or user variance.A clinical investigation concluded: per e-mail communication ¿the product has not been used on a patient and it has not resulted in any injury.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The associated risk file contains the reported event.The instructions for use provides comprehensive instructions of the operation, use and limitations of the device.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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.

• Brand Name: OPSITE POST-OP VISIBLE 10 X8CM CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11072196
• MDR Text Key: 223606851
• Report Number: 8043484-2020-04383
• 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,Followup
• Report Date: 03/19/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 03/03/2021
• Supplement Dates FDA Received: 12/24/2020; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention