EST+ DRNPRECUTINVISICLR38MM(1X10) NAI 421024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for EST+ DRNPRECUTINVISICLR38MM(1X10) NAI 421024 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[128894154] (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


[128894155] It was reported the starter hole was off center in three wafers. The product was not used and no photo was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2018-03652
MDR Report Key8115744
Date Received2018-11-29
Date Mfgr Received2018-11-12
Date Added to Maude2018-11-29
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 NameEST+ DRNPRECUTINVISICLR38MM(1X10) NAI
Generic NameNOT APPLICABLE
Product CodeEXB
Date Received2018-11-29
Model Number421024
Lot Number8C03437
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 2018-11-29

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