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.
[5034405]
While wearing the shoe covers, a nurse fell and crushed her elbow. She turned to the right and her feet flew out from under her to the left. The floor was dry. She required surgery and is expected to be off work for several weeks.
Patient Sequence No: 1, Text Type: D, B5
[12567309]
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 first 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
| Report Number | 1423537-2014-00030 |
| MDR Report Key | 4276942 |
| Report Source | 04,07 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-10-29 |
| Date Mfgr Received | 2014-11-03 |
| Device Manufacturer Date | 2014-07-02 |
| Date Added to Maude | 2014-11-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Street | 80 ANSON ROAD |
| Manufacturer City | SINGAPORE 079907 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 079907 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOECOVER DURA FIT XL 200/PR |
| Generic Name | COVER, SHOE, OPERATING-ROOM |
| Product Code | FXP |
| Date Received | 2014-11-25 |
| Returned To Mfg | 2014-11-14 |
| Catalog Number | 4854 |
| Lot Number | 14GEF182 |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Address | 80 ANSON ROAD SINGAPORE 079907 SN 079907 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-11-25 |