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

Model Number 66000016

Device Problem Failure to Unfold or Unwrap (1669)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Postal code (b)(6).

Event Description

It was reported that, during treatment, one box of profore 18-25cm ankle circ.Case 8 had the 4th layer very hard to pull out and roll on the patient's legs.Also, eventually some of this 4th layer were torn due to clinicians had to use force to pull it out.It occurred randomly for this batch.Clinicians concern that this might affect the compression pressure and treatment outcomes.It consumes huge nursing time and might not achieve desirable compression pressure too.This happened before use in patient.Treatment was performed, with a delay less than or equal to 30mins, with a smith and nephew back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.The photographs provided have been reviewed and show evidence of the reported failure, confirming a relationship between the device and the reported event.A review of the manufacturing records confirmed the device was released according to specification, complaint history review found further instances.A review of the manufacturing process was performed, and a root cause of inadequate standard operating procedure has been assigned.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: 12657793
• MDR Text Key: 277185539
• Report Number: 8043484-2021-01897
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 66000016
• Device Catalogue Number: 66000016
• Device Lot Number: 1117454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2020
• 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