NATURA 402203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for NATURA 402203 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[125767349] Based on the available information, this event is deemed to be a reportable malfunction. An investigation was performed to determine the root cause associated with the investigation wafer disc decentralization, complaint malfunction (skin barrier starter hole is defective, e. G. Misalignment or off center, leakage may occur), for lots manufactured in (b)(4). The cause and effect investigation was performed.? It was determined that the following probable root causes and opportunities were identified: machinery is the root cause of this incident.? It is concluded that all the machinery/ tooling items complied when compared against drawing specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process. Observations include:? Misalignment of the wafer loading pins, misalignment of the upper wafer loading plate and fixation of the upper wafer loading plate and lower wafer loading plate. Actual testing method of (random hourly sampling) may not effectively capture the defects prior to packaging, it is suggested the implementation of a continuous testing method to anticipate to all of the peaks. A certification of the operators who have direct influence due to the? Flange/wafer loading? Process in operations, to reduce the learning curve effect in process and guarantee the training effectiveness. This should be performed in conjunct with the quality inspector, process engineer of such line and the supervisor. Actions will be taken for each factor and will be summarized on a corrective action / preventive actions (capa) plan. The investigation associated with this event is approved and complete.? 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[125767350] It was reported there was an uneven dimension of the tape border in 25 wafers. Photos were received (b)(6) 2018 that showed the hole was off center. No harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2018-02609
MDR Report Key8024495
Date Received2018-10-31
Date Mfgr Received2018-10-09
Date Added to Maude2018-10-31
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 DOMINICAN REPUBLIC INC
Manufacturer StreetKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA
Manufacturer CitySAN CRISTOBAL
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNATURA
Generic NameNOT APPLICABLE
Product CodeEXB
Date Received2018-10-31
Model Number402203
Lot Number7K03422
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC DOMINICAN REPUBLIC INC
Manufacturer AddressKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-31

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