MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-08-04 for DURAFIT SHOECOVER, ANTISKID 4852 manufactured by Allegiance Healthcare Corp..
[150108]
It has been reported that in may 2000, a surgical assistant slipped and fell while wearing the shoe covers. The shoe covers were moist and had been worn for about 1 1/2 hrs. While transferring a pt from the or table to a cart, the employee fell and sustained blunt trauma to the head by hitting the or table and then the floor. The employee was off work for about 6 weeks and still has some memory deficits. There is a history of previous concussion in an auto accident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00201 |
| MDR Report Key | 288350 |
| Report Source | 05,06 |
| Date Received | 2000-08-04 |
| Date of Report | 2000-08-04 |
| Date of Event | 2000-05-01 |
| Date Mfgr Received | 2000-07-26 |
| Date Added to Maude | 2000-08-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN RD. |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAFIT SHOECOVER, ANTISKID |
| Generic Name | DURAFIT SHOECOVER, ANTISKID |
| Product Code | FXP |
| Date Received | 2000-08-04 |
| Model Number | 4852 |
| Catalog Number | 4852 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 279046 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | DURAFIT SHOECOVER, ANTISKID |
| Baseline Generic Name | DURAFIT SHOECOVER |
| Baseline Model No | 4852 |
| Baseline Catalog No | 4852 |
| Baseline ID | NA |
| Baseline Device Family | APPAREL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K800528 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-08-04 |