#N/A 420824

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-01 for #N/A 420824 manufactured by Convatec Ltd.

Event Text Entries

[141324372] (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. A batch record review indicates no discrepancies. Machine logs have been checked and no discrepancies were found. Preventive maintenance (pm) logs were checked and all pms were completed with no issues found. Lot # 8h03070 was sterilized under lot 1216022711 and released on review of results of sterilization. All of the results were within specification and products were released in compliance with standard operating procedures. The production process, in process testing and packaging of products was run in accordance with process instructions for machine doyen 3. Visual inspection was performed in accordance with test methods and was completed at the beginning of the order and every hour following until the order was complete. No nonconformity was raised during the manufacturing process of lot 8h03070. This is the only complaint for the affected lot registered within (b)(4). Two (2) photographs have been received for this issue and have been evaluated in accordance with work instructions. The photographs confirm the complaint issue, the lot number and that this is the product expected. The photographs show dark specks on the dressings however as the dressings are no being returned it cannot be confirmed what the foreign matter is. Operators will be made aware of the complaint issue. 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. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[141324373] It was reported "one of the corner is covered in dots of mold. The pocket was sealed properly too". Photos depicting the reported complaint issue were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000317571-2019-00037
MDR Report Key8470209
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-04-01
Date Mfgr Received2019-03-08
Date Added to Maude2019-04-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer G1CONVATEC LTD
Manufacturer StreetFIRST AVENUE DEESIDE INDUSTRIAL PARK
Manufacturer CityDEESIDE, FLINTSHIRE CH5 2NU
Manufacturer CountryUK
Manufacturer Postal CodeCH5 2NU
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name#N/A
Generic NameNOT APPLICABLE
Product CodeNAC
Date Received2019-04-01
Model Number420824
Lot Number8H03070
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC LTD
Manufacturer AddressFIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-01

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