MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE 18-25CM ANKLE CIRC. CASE 8; BANDAGE, ELASTIC

Model Number 66000016

Device Problems Product Quality Problem (1506); Failure to Unfold or Unwrap (1669)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during treatment, in four boxes of profore 18-25cm ankle circ.Case 8, the 4th layer was very hard to pull out and to roll on patients¿ legs, the adhesiveness was very tight compares with other batches.It was also reported that the quality was not consistent, the diameter of this layer roll was different individually.It is unknown how treatment was completed.No harm to the patient or any further complications reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.A complaint history review was performed for the product and event description, there have been further instances of this nature.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PROFORE 18-25CM ANKLE CIRC. CASE 8
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12606495
• MDR Text Key: 276578214
• Report Number: 8043484-2021-01848
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 05031844000746
• UDI-Public: 05031844000746
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 66000016
• Device Catalogue Number: 66000016
• Device Lot Number: 1108350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1