MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-17 for SHOECOVER DURA FIT XL 200/PR 4854 manufactured by Cardinal Health.
[2918964]
When walking in the or, a nurse lost her balance due to her perception of slippery shoe covers. She slipped and fell. She had an mri, physical therapy, and was put on light duty for 2 weeks. There apparently were no wet areas or any disruption noted in the flooring.
Patient Sequence No: 1, Text Type: D, B5
[10432865]
The customer provided the lot number. Therefore the device history record was reviewed. It showed that there was no exception recorded that could result in the reported defect. The coefficient of friction measured during production for this lot number met specification. Historical trending was done. The sample was not provided. Without the sample, the failure cannot be confirmed and the root cause of the failure cannot be determined from this investigation. The relevant production personnel were made aware of the complaint. At this time there is no corrective action. We will continue to monitor for any trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2012-00039 |
| MDR Report Key | 2794270 |
| Report Source | 05,07 |
| Date Received | 2012-10-17 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-09-25 |
| Date Mfgr Received | 2012-09-26 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2012-10-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| 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 | 2012-10-17 |
| Catalog Number | 4854 |
| Lot Number | 12FCF154 |
| Device Expiration Date | 2017-06-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-17 |