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

Model Number	168210
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The heath care professional reported that while checking before usage, the package seal was found opened.The product was not used on patient.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Complainant country: (b)(6).Contact office address: (b)(6).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.Fda registration number: (b)(4).
Additional Manufacturer Narrative
Complainant country: (b)(6).Contact office address: (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
The heath care professional reported that while checking before usage, the package seal was found opened.The product was not used on patient.Photographs depicting the issue were received from the complainant.
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: 13087145
• Report Number: 1000317571-2021-00254
• Device Sequence Number: 5333973
• 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,Health Professional
• Initial Reporter Occupation: Other
• 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: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 168210
• Device Lot Number: 0C04345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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