NATURA 413182

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 2020-03-31 for NATURA 413182 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[186106471] Device 175 of 188. (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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186106472] It was reported that 188 out of 460 wafers from the same lot had an off centered starter hole. The affected products were not used on patients. Photographs depicting the issue were received from the complainant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2020-09209
MDR Report Key9908963
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-31
Date Mfgr Received2020-03-19
Date Added to Maude2020-03-31
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 Phone3365424681
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 Report3

Device Details

Brand NameNATURA
Generic NamePROTECTOR, OSTOMY
Product CodeEXE
Date Received2020-03-31
Model Number413182
Lot Number9H04507
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-31

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