SHOECOVER DURA FIT XL 200/PR 4854

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-11-25 for SHOECOVER DURA FIT XL 200/PR 4854 manufactured by Cardinal Health Singapore 225 Pte Ltd.

Event Text Entries

[5034413] While wearing the shoe covers, a nurse slipped and caught herself, but in the process wrenched/strained her back and had pain for several hours afterwards. She took advil and applied heat. She is fine now and has no complaints at this time. The floor had not been recently washed/waxed.
Patient Sequence No: 1, Text Type: D, B5


[12567334] The device history record (dhr) was reviewed, and no exception was recorded during production of this lot. The dhr indicated that the coefficient of friction was meeting the specification when it was first produced, it was noted that the cof was found to deteriorate through time usually in storage. This appears to be an inherent characteristic of the shoe cover. The root cause for the deterioration cannot be identified at this time. Currently, there are no documented criteria for coefficient of friction. As a result, cardinal health has utilized the osha guidelines for floor conditions to be slip-resistant and have a static coefficient of friction (scof) value of 0. 5 or greater. Cardinal health has an internal coefficient friction of 0. 68. Historical trending was done and this is the second report of slipperiness in the past twelve months for this catalog number. The complaint was fed back to the relevant section of production for awareness. A refresher training session was conducted for the operators to ensure they strictly comply with the specification and production methods. A capa project was raised to analyze the cause of the deterioration and the action needed to contain and correct the issue. At this time, no additional corrective actions will be taken, but we will continue to monitor complaints for trends of this issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423537-2014-00031
MDR Report Key4277054
Report Source04,07
Date Received2014-11-25
Date of Report2014-11-25
Date of Event2014-10-30
Date Mfgr Received2014-11-03
Device Manufacturer Date2014-07-02
Date Added to Maude2014-11-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMICHELE DONATICH
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478876412
Manufacturer G1CARDINAL HEALTH SINGAPORE 225 PTE LTD
Manufacturer Street80 ANSON ROAD
Manufacturer CitySINGAPORE 079907
Manufacturer CountrySN
Manufacturer Postal Code079907
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHOECOVER DURA FIT XL 200/PR
Generic NameCOVER, SHOE, OPERATING-ROOM
Product CodeFXP
Date Received2014-11-25
Returned To Mfg2014-11-14
Catalog Number4854
Lot Number14GEF182
OperatorNURSE
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH SINGAPORE 225 PTE LTD
Manufacturer Address80 ANSON ROAD SINGAPORE 079907 SN 079907


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-11-25

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