MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2003-12-09 for SHOE COVER, ANTI-SKID 2852 manufactured by Cardinal Health.
[341336]
Not sufficent tread to prevent falling. One nurse slipped and fell while wearing shoe covers. It is not known what the condition of the floor was or what activity the nurse was performing. The nurse hit their elbow and went to urgent care. The treatment was tylenol, ice and rest. The nurse missed 2 days of work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00145 |
| MDR Report Key | 499991 |
| Report Source | 06,07 |
| Date Received | 2003-12-09 |
| Date of Report | 2003-12-09 |
| Date Mfgr Received | 2003-11-10 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2003-12-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGRAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | SURGICAL GROUP EL PASO |
| Manufacturer Street | ONE BUTTERFIELD RD |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, ANTI-SKID |
| Generic Name | SHOE COVER, ANTI-SKID |
| Product Code | FXP |
| Date Received | 2003-12-09 |
| Model Number | 2852 |
| Catalog Number | 2852 |
| Lot Number | 03HAK2375 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 488758 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | SHOE COVER, ANTI-SKID |
| Baseline Generic Name | SHOE COVER, ANTI-SKID |
| Baseline Model No | 2852 |
| Baseline Catalog No | 2852 |
| Baseline Device Family | APPAREL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-09 |