MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-10 for SHOECOVER/ANTISKID/FLUIDREST/UNI 4872A manufactured by Cardinal Health.
[2410049]
Circulating rn slipped and fell in the or. Apparently there was nothing on the floor. She hit her head, and briefly lost consciousness. She went to the er, and a cat scan and head x-rays were done. She had a concussion. She returned to work on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[9682543]
Unfortunately the customer could not provide the lot number, and the sample was discarded in the er. Without the lot number, we are not able to review the device history record to identify if there was any exception during the manufacture of these shoe covers. Without the sample, we are not able to determine the root cause of the reported failure. Historical trending of this product code was done, and no trend was identified. Production personnel were made aware of this complaint, and we will continue to monitor for trends. The nurse's age was identified as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2012-00001 |
| MDR Report Key | 2406727 |
| Report Source | 05,07 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-01-10 |
| 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 | 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/ANTISKID/FLUIDREST/UNI |
| Generic Name | SHOE COVER WITH ANTI SKID SOLE |
| Product Code | FXP |
| Date Received | 2012-01-10 |
| Catalog Number | 4872A |
| Lot Number | NO LOT GIVEN |
| 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 | 2012-01-10 |