MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-15 for XTRA TRACTION SHOE COVER 69252 manufactured by Kimberly-clark Corp..
[495195]
A hospital worker slipped while wearing shoe covers and fell and required four stitches on their face. The individual returned to work with no other medical treatment being necessary.
Patient Sequence No: 1, Text Type: D, B5
[7798377]
The device was not returned for evaluation. There have been no changed to the shoe covers, and they have extra traction strips on the bottom of the shoe covers. The cartons of shoe covers contain the following caution statement: "caution: the risk of slipping exists, especially on waxed or wet floors. Remove when contaminated or when leaving work area. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033422-2006-00047 |
| MDR Report Key | 761143 |
| Report Source | 05,06 |
| Date Received | 2006-09-15 |
| Date of Report | 2006-09-15 |
| Date of Event | 2006-08-29 |
| Date Added to Maude | 2006-09-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | LARRY KLUDT |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD. |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878279 |
| Manufacturer G1 | KUNSHAN SANDRA PACKAGING, INC. |
| Manufacturer Street | * |
| Manufacturer City | JIANGSU PROVINCE |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XTRA TRACTION SHOE COVER |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2006-09-15 |
| Model Number | NA |
| Catalog Number | 69252 |
| Lot Number | CA6005008 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749065 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-15 |