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

Model Number	66000016
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Initial reporter postal code: (b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has not been returned for evaluation.Images have been supplied confirming individual layers were tightly glued to one anothe.A relationship against the reported event has been established.A complaint history review confirmed further instances of this nature.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.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
• Common Device Name: 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: 12657705
• Report Number: 8043484-2021-01896
• Device Sequence Number: 4489921
• Product Code: FQM
• UDI-Device Identifier: 05031844000746
• UDI-Public: 05031844000746
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown