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

Model Number	168210
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This emdr is being submitted for each individual patient since there have been three instances recently of different dressings which was sticking and difficult to remove from three different patients.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.It was not possible to complete a batch record review, as the batch number reported under complaint could not be obtained (cno).The product reported under complaint was kaltostat drs 5x5cm (1x10pk) ster int.The kaltostat product under complaint has a 3 year shelf life, and when checking this material code in sap, the last product manufactured on this material code was manufactured 28 february 2019, so would have had an expiry date of 27 february 2022.Based on these findings, as the complaint was received after this date in may 2022, it is likely that the product under complaint was outside of its expiry date when it was used on the patient.It is likely that the issues reported under complaint for the dressings are resulting from the product being used outside of its expiry date period.No harms have been reported for either of the three related complaint records raised for this product.Territory manager's name: (b)(6).Territory manager's contact information: (b)(6).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.
Event or Problem Description
It was reported by clinician to the territory manager that one out of one dressing on one patient was sticking and had difficulty in removal.This product was regularly used at this medical facility.Product was being placed on skin donor sites.No prior issues at this facility with this product have been reported before.No photo is available at this time.

• 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: 14798220
• Report Number: 1000317571-2022-00090
• Device Sequence Number: 5812754
• Product Code: NAC
• UDI-Device Identifier: 00768455122783
• UDI-Public: 00768455122783
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: 168210
• 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: 05/27/2022
• Initial Report FDA Received Date: 06/24/2022
• 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