MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2008-07-28 for SHOE COVER, NON-SKID, SPORT SIZ NON28752 manufactured by Medline Industries, Inc..
[914782]
A consultant was walking through the facility. She was wearing a pair of shoe covers and slipped. She fractured her wrist.
Patient Sequence No: 1, Text Type: D, B5
[8112162]
The end user involved in the incident is a consultant that was hired by the surgery center to help get it up and running. She apparently went back into one of the surgical suites, wearing a pair of sports size shoe covers and was told to be careful because the floor was slippery. She slipped and fractured her wrist. The wrist was casted. The sample was returned and evaluated. The sample was found to be within spec. Unable to determine the root cause for the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2008-00020 |
| MDR Report Key | 1085179 |
| Report Source | 00,05 |
| Date Received | 2008-07-28 |
| Date of Report | 2008-07-23 |
| Date Facility Aware | 2008-06-25 |
| Date Added to Maude | 2009-05-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, NON-SKID, SPORT SIZ |
| Generic Name | NONE |
| Product Code | FXP |
| Date Received | 2008-07-28 |
| Model Number | NON28752 |
| Lot Number | 83616640-3 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2008-07-28 |