MAUDE Adverse Event Report: UNOMEDICAL UK L3C1950 - UNO OR/SECUREMENT; ACCESSORIES, CATHETER

Model Number	037449
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the past flexi-trak have resulted in skin tears or have dislodged after 1-2 days of use.
Additional Manufacturer Narrative
Complainant city: bunbury.Complainant state/province: wa.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore; this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

• Brand Name: L3C1950 - UNO OR/SECUREMENT
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): UNOMEDICAL UK; convatec ltd gdc, first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): UNOMEDICAL UK; convatec ltd gdc, first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14355652
• Report Number: 1000317571-2022-00076
• Device Sequence Number: 2367489
• Product Code: KGZ
• UDI-Device Identifier: 00768455200658
• UDI-Public: 00768455200658
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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 Model Number: 037449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown