MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-08-18 for VALUPAK SHOECOVERS, NON-COND 4831 manufactured by Allegiance Healthcare Corp..
[187143]
Plaintiff, while wearing shoe covers, lost traction slipped and fell in the gowning room adjacent to the operating room at the hosp. No specific injuries are described.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00212 |
| MDR Report Key | 291409 |
| Report Source | 00 |
| Date Received | 2000-08-18 |
| Date of Report | 2000-08-18 |
| Date of Event | 1997-08-18 |
| Date Mfgr Received | 2000-08-15 |
| Date Added to Maude | 2000-08-23 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | VALUPAK SHOECOVERS, NON-COND |
| Generic Name | VALUPAK SHOECOVERS, NON-COND |
| Product Code | FXP |
| Date Received | 2000-08-18 |
| Model Number | 4831 |
| Catalog Number | 4831 |
| 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 | 282037 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | VALUPAK SHOECOVERS, NON-COND |
| Baseline Generic Name | SHOECOVERS, NON-COND |
| Baseline Model No | 4831 |
| Baseline Catalog No | 4831 |
| 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 | 2000-08-18 |