MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-19 for BOOT COVER B77-5032 * manufactured by Broadline Medical, Inc.
[3172472]
Knee high bootie covers were used in the labor and delivery are permeable. The doctor removed the covers to discover the shoes were contaminated with fluids. What was the original intended procedure? To protect the staff's shoes and clothing from contamination of fluids, especially bodily fluids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2992511 |
| MDR Report Key | 2992511 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-01-25 |
| Date of Event | 2013-01-20 |
| Report Date | 2013-01-25 |
| Date Reported to FDA | 2013-02-19 |
| Date Reported to Mfgr | 2013-03-07 |
| Date Added to Maude | 2013-03-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOOT COVER |
| Generic Name | SHOE COVER, KNEE HIGH |
| Product Code | FXP |
| Date Received | 2013-02-19 |
| Model Number | B77-5032 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROADLINE MEDICAL, INC |
| Manufacturer Address | 2100 ATLAS ROAD SUITE E RICHMOND CA 94806 US 94806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-19 |