MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-12-04 for SHOE COVER, ANTI-SKID 2852 manufactured by Allegiance Healthcare.
[279242]
Two pregnant staff members slipped and fell while wearing shoecovers. One staff member went to the emergency room and was observed for 4 hours. There was no injury and they returned to full duty. The other staff member went to their own ob/gyn md and their evaluation showed no injuries and they also returned to full duty. There were no negative outcomes due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2002-00154 |
| MDR Report Key | 430984 |
| Report Source | 05,07 |
| Date Received | 2002-12-04 |
| Date of Report | 2002-12-04 |
| Date of Event | 2002-11-11 |
| Date Mfgr Received | 2002-11-21 |
| Date Added to Maude | 2002-12-06 |
| 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 | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2002-12-04 |
| Model Number | 2852 |
| Catalog Number | 2852 |
| Lot Number | 19846 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 419967 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1430 WAUKEGAN ROAD 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 | 2002-12-04 |