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

Model Number	66000016
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that before treatment with a profore 18-25cm ankle circ.Case 8 the material is very hard to pull out and to roll on the patient leg.Also the adhesiveness is very tight compared to other batches, which might affect the compression pressure and patient outcome.The therapy was completed with the same product, requiring it to be pull out and trimmed part by part to achieve the compression pressure.No patient harm reported.
Additional Manufacturer Narrative
The device, intended for use 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 found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, a complaint history review confirmed further instances of this nature.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
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12539752
• Report Number: 8043484-2021-01792
• Device Sequence Number: 1508026
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/10/2021
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown