MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-09 for SHOE COVER, SMS, NONSKID, REG SZ NON28858 manufactured by Medline Industries, Inc..
[1007402]
Reportedly, staff member fell while wearing the shoe covers. A small amount of water was on the floor.
Patient Sequence No: 1, Text Type: D, B5
[8156338]
A staff member in the or was taking instruments into the decontamination area. She fell on her right side and injured her thumb, elbow, hip and ankle. A mri was done and no fractures were identified. She returned to work on restricted duties. The director of surgery identified a number of factors, which may have contributed to the incident. There was a small amount of water on the floor. The caution statement on the package states that hospital floors are sometimes wet and that personnel who wear shoe covers should be aware that a risk of slipping exists and that precautions should be taken. In the future, the facility will place a large mat to catch any dripping from the wet instruments. Another factor was the shoes worn by the end user. The facility did not feel the heel was appropriate for use with shoe covers in the or. The last factor relates to the fact that this was not the first injury for this employee. The facility plans to conduct staff training concerning safety protocols in the or.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00003 |
| MDR Report Key | 1297466 |
| Report Source | 05 |
| Date Received | 2009-01-09 |
| Date of Report | 2009-01-08 |
| Date of Event | 2008-12-08 |
| Date Facility Aware | 2008-12-09 |
| Date Added to Maude | 2009-12-09 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, SMS, NONSKID, REG SZ |
| Generic Name | NONE |
| Product Code | FXP |
| Date Received | 2009-01-09 |
| Model Number | NON28858 |
| Lot Number | 83963325-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-09 |