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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LTD L3W0250 - KALTOSTAT; DRESSING,WOUND,HYDROPHILIC
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CONVATEC LTD L3W0250 - KALTOSTAT; DRESSING,WOUND,HYDROPHILIC Back to Search Results
Model Number 168210
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event 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.
 
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).
 
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 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 Description
To date no additional patient or event details have been received.
 
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Brand Name
L3W0250 - KALTOSTAT
Type of Device
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 Key13087145
MDR Text Key286350549
Report Number1000317571-2021-00254
Device Sequence Number1
Product Code NAC
UDI-Device Identifier00768455122783
UDI-Public00768455122783
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Expiration Date03/01/2023
Device Model Number168210
Device Lot Number0C04345
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/27/2021
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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