MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-06-29 for BASIC X-TRA TRACTION SHOE COVER 69015 manufactured by Kimberly-clark Corp..
[400127]
An individual was wearing the shoe cover and the floor was dry and had been waxed one week earlier. The individual fell and required knee surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616096-2005-00041 |
| MDR Report Key | 618040 |
| Report Source | 06,07 |
| Date Received | 2005-06-29 |
| Date of Report | 2005-06-29 |
| Date of Event | 2005-06-02 |
| Date Mfgr Received | 2005-06-02 |
| Date Added to Maude | 2005-06-30 |
| 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 | DICK WOLFE |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878208 |
| Manufacturer G1 | KIMBERLY-CLARK CORP. |
| Manufacturer Street | * |
| Manufacturer City | ACUNA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASIC X-TRA TRACTION SHOE COVER |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2005-06-29 |
| Model Number | NA |
| Catalog Number | 69015 |
| Lot Number | UNAVAILABLE |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 607726 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US |
| Baseline Brand Name | BASIC X-TRA TRACTION SHOE COVER |
| Baseline Generic Name | SHOE COVER |
| Baseline Model No | NA |
| Baseline Catalog No | 69015 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-06-29 |