MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-12 for DURAFIT SHOECOVER, ANTISKID 4852 manufactured by Allegiance Healthcare Corp.
[184394]
It has been reported that an employee working in the operating room slipped and fell while wearing the shoe covers for approx 4 hours. Employee was sent the occupational health resource center at the hosp to be checked out. No medical treatment was required. Employee was released back to work on lite duty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1999-00330 |
| MDR Report Key | 249982 |
| Report Source | 05 |
| Date Received | 1999-11-12 |
| Date of Report | 1999-11-12 |
| Date of Event | 1999-10-19 |
| Date Mfgr Received | 1999-10-25 |
| Date Added to Maude | 1999-11-18 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8477853309 |
| 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 | 1999-11-12 |
| Returned To Mfg | 1999-11-08 |
| Model Number | 4852 |
| Catalog Number | 4852 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 242190 |
| 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. Other | 1999-11-12 |