MAUDE Adverse Event Report: CONVATEC LTD L3W0250 - KALTOSTAT; DRESSING,WOUND,HYDROPHILIC

Model Number	168210
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was mixed in the individual packaging.The product was not used.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
(b)(6).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: L3W0250 - KALTOSTAT
• Common Device Name: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; 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: 13087112
• Report Number: 1000317571-2021-00248
• Device Sequence Number: 5319881
• Product Code: NAC
• UDI-Device Identifier: 00768455122783
• UDI-Public: 00768455122783
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: Other
• Device Expiration Date: 03/01/2023
• Device Model Number: 168210
• Device Lot Number: 0G00233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown