MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-21 for SHOE COVER CRI2002 manufactured by Medline Industries, Inc..
[3841842]
It was reported that the end user stepped on the shoe cover and fell. The extent of any injuries is not known but she was off work for a week.
Patient Sequence No: 1, Text Type: D, B5
[10923365]
It was reported that an employee was at lunch in the breakroom of the operating room and fell when she stepped on the shoe cover. The facility indicated the shoe cover was too big. The employee was evaluated in the er and was off work for one week. The extent of injuries is not known. The actual sample was not returned. Samples from the same reported lot were returned and evaluated. Measurements of the shoe cover were within specification and the issue could not be confirmed. It is not known of the end user was wearing the correct sized shoe cover. It is also not known if the condition of the floor in breakroom contributed to the reported incident. We have had no other similar incidents reported to us this yr for this device and no corrective action is being taken. Due to the reported leave of absence from work, and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00066 |
| MDR Report Key | 3313259 |
| Report Source | 06 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-21 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-07-23 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2013-08-21 |
| Catalog Number | CRI2002 |
| Lot Number | 13DXFA0045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2013-08-21 |