POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-25 for POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 1 manufactured by K-c Afc Manufacturing, S. De R.l. De C.v.

Event Text Entries

[181152052] A manufacturer lot code was not provided. With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.
Patient Sequence No: 1, Text Type: N, H10


[181152053] Consumer reported on behalf of a friend that she used a bladder support and upon removal, the string came out and she was unable to manually remove. Her friend went to the er for removal of the bladder support. Consumer did not provide any more details of her friend's experience.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011109575-2020-00612
MDR Report Key9750676
Report SourceCONSUMER
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2019-12-25
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-25
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 Received2020-02-25
Model NumberSIZE 1
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 2020-02-25

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