POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 3

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 2020-03-16 for POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 3 manufactured by K-c Afc Manufacturing, S. De R.l. De C.v.

Event Text Entries

[183652729] Review of the device history record (dhr), supporting quality records, and unused companion samples confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10


[183652730] The consumer reported that part of the outer fabric of the bladder support was missing after removal and the inner silicone was exposed. She did not seek medical attention but called her doctor to inform them what happened. Consumer stated she was doing fine after her experience with the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011109575-2020-00632
MDR Report Key9836251
Report SourceCONSUMER
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-01-29
Date Mfgr Received2020-02-28
Device Manufacturer Date2018-09-02
Date Added to Maude2020-03-16
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 Received2020-03-16
Returned To Mfg2020-03-09
Model NumberSIZE 3
Lot NumberNN824671A
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-03-16

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