MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-16 for SHOE COVER, SMOOTH BOTTOM CRI2000 manufactured by Medline Industries, Inc..
[4094211]
The clinician slippered and fell while wearing the show cover. She was reported to be off work but a specific injury was not reported.
Patient Sequence No: 1, Text Type: D, B5
[11490972]
The clinician slipped and fell while wearing the show cover and apparently was off work due to the fall. We attempted to gather specific details pertaining to the incident and confirm the extent of any injuries but did not receive additional information. The shoe covers have smooth bottoms and do not have slip resistant treads. The condition of the floor surface is not known or if the correct shoe cover size was being worn at the time of the fall. There is no sample to evaluate and no lot number was provided. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00004 |
| MDR Report Key | 3600511 |
| Report Source | 05,06 |
| Date Received | 2014-01-16 |
| Date of Report | 2014-01-10 |
| Date of Event | 2013-12-12 |
| Date Mfgr Received | 2013-12-13 |
| Date Added to Maude | 2014-02-03 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, SMOOTH BOTTOM |
| Product Code | FXP |
| Date Received | 2014-01-16 |
| Catalog Number | CRI2000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-01-16 |