WINGS 958B10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-13 for WINGS 958B10 manufactured by Covidien.

Event Text Entries

[79973479] Submit date: 07/13/17. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[79973480] The customer had problems with product. Product would cause pressure ulcers to patients and when it tore it would leave particles every where, contaminating sterile areas and getting into wounds.
Patient Sequence No: 1, Text Type: D, B5


[113460252] Submit date: 1/19/2018. An investigation of the reported condition was performed. Because the customer did not supply a recognizable manufacturing lot number, it was not possible to review the device history record (dhr) for this complaint. Because a physical sample/photo was not provided an investigation could not have been completed, therefore the failure mode could not be verified either. Our raw materials are tested for biocompatibility prior to use and there have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients. Based on the complaint trending information, our corrective actions are to notify plant management in order to increase awareness of the issue. Complaint trending will continue to be monitored and corrective actions will be implemented if an increase of this failure mode occurs. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[113460253]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1033903-2017-05000
MDR Report Key6711971
Report SourceDISTRIBUTOR
Date Received2017-07-13
Date of Report2018-01-19
Date of Event2017-06-13
Date Mfgr Received2017-06-15
Date Added to Maude2017-07-13
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 N.EMERALD ROAD
Manufacturer CityGREENWOOD SC 29646
Manufacturer CountryUS
Manufacturer Postal Code29646
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWINGS
Generic NameBEDDING, DISPOSABLE, MEDICAL
Product CodeKME
Date Received2017-07-13
Model Number958B10
Catalog Number958B10
Lot Number664M71339
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address525 N.EMERALD ROAD GREENWOOD SC 29646 US 29646


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-13

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