STAPH CHECK II PILLOW * 000SC1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-28 for STAPH CHECK II PILLOW * 000SC1 manufactured by Herculite Products, Inc..

Event Text Entries

[21960807] Hosp used a pillow, after pillow was sanitized, hosp employee looked inside pillow & found an area that had been contaminated with a bodily fluid & blood. Pillow seemed to be able to let a fluid penetrate to inside contents. Was not known how long pillow had been saturated. A pillow was put in its place. A pillow case was used on this reusable pillow for every use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1011965
MDR Report Key116095
Date Received1997-08-28
Date of Report1997-08-26
Date of Event1997-08-05
Date Added to Maude1997-09-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTAPH CHECK II PILLOW
Generic NamePILLOW
Product CodeKME
Date Received1997-08-28
Model Number*
Catalog Number000SC1
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key113915
ManufacturerHERCULITE PRODUCTS, INC.
Manufacturer AddressP.O. BOX 786 YORK PA 17405 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-08-28

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