POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-12 for POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 2 manufactured by K-c Afc Manufacturing, S. De R.l. De C.v.

Event Text Entries

[183157110] Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10


[183157111] This is a non-us event. This occurred in (b)(6). Consumer reported the string was fully unattached prior to use and in the wrapper with the bladder support. She did not use the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011109575-2020-00626
MDR Report Key9825369
Report SourceCONSUMER,FOREIGN
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-18
Date Mfgr Received2020-02-21
Device Manufacturer Date2018-02-01
Date Added to Maude2020-03-12
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 ContactMRS. EMILY ARNOULD, RN BSN
Manufacturer Street2100 WINCHESTER RD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207213128
Manufacturer G1K-C AFC MANUFACTURING, S. DE R.L. DE C.V
Manufacturer StreetCALZADA INDUSTRIAL DE LAS MAQUILADORAS #87 NUEVO NOGALES
Manufacturer CityNOGALES, SONORA MEXICO 84094
Manufacturer CountryMX
Manufacturer Postal Code84094
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOISE IMPRESSA : PESSARY, VAGINAL : HHW
Generic NamePESSARY, VAGINAL
Product CodeHHW
Date Received2020-03-12
Model NumberSIZE 2
Lot NumberNN803271A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerK-C AFC MANUFACTURING, S. DE R.L. DE C.V
Manufacturer AddressCALZADA INDUSTRIAL DE LAS MAQUILADORAS #87 NUEVO NOGALES NOGALES, SONORA MEXICO 84094 MX 84094


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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