WINGS QUILTED MVP 30X36 P3036MVP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-08-27 for WINGS QUILTED MVP 30X36 P3036MVP manufactured by Covidien.

Event Text Entries

[118289205] The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10


[118289206] The customer reports the product does not absorb the fluids and has torn on some patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1033903-2018-00200
MDR Report Key7818207
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-08-27
Date of Report2018-08-27
Date of Event2018-08-02
Date Mfgr Received2018-08-02
Date Added to Maude2018-08-27
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street525 NORTH EMERALD RD
Manufacturer CityGREENWOOD SC 29646
Manufacturer CountryUS
Manufacturer Postal Code29646
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWINGS QUILTED MVP 30X36
Generic NameGARMENT, PROTECTIVE, FOR INCONTINENCE
Product CodeEYQ
Date Received2018-08-27
Model NumberP3036MVP
Catalog NumberP3036MVP
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address525 NORTH EMERALD RD GREENWOOD SC 29646 US 29646


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.