MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE KIT LFF CASE 8; BANDAGE, ELASTIC

Model Number 66020626

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that twenty seven (27) profore kit latex free are super sticky and hard to pull off the roll as if they were super glued.They are also ripping and have holes.Treatment was resumed, after a non-significant delay, with a competitor's back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: PROFORE KIT LFF 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: 13501909
• MDR Text Key: 286049104
• Report Number: 8043484-2022-00058
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 05031844013883
• UDI-Public: 05031844013883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66020626
• Device Catalogue Number: 66020626
• Device Lot Number: 1361857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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