MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for KIMBERLY-CLARK OPERATING ROOM SHOE COVER 69254 manufactured by Halyard Health, Inc..
[51157367]
Patient Sequence No: 1, Text Type: N, H10
[51157368]
The non skid soles of the halyard shoe cover xl ps #68628, product number 69254, and boot full cover ps# 8450 (product number 69671) disintegrate and leave small white confetti looking debris on the floor of our rooms, hallways and other patient care areas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5846309 |
| MDR Report Key | 5846309 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-07-20 |
| Report Date | 2016-07-26 |
| Date Reported to FDA | 2016-07-26 |
| Date Reported to Mfgr | 2016-07-26 |
| Date Added to Maude | 2016-08-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIMBERLY-CLARK OPERATING ROOM SHOE COVER |
| Generic Name | COVER,SHOE, OPERATING-ROOM |
| Product Code | FXP |
| Date Received | 2016-08-04 |
| Model Number | 69254 |
| Lot Number | CA6051001 |
| ID Number | PS68628 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-04 |