MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-02-14 for KC BASIC XTRA TRACTION SHOE COVER 69352 manufactured by Kimberly-clark Corp..
[16035357]
A hospital staff member fell and sprained the elbow while wearing the shoe covers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625443-2001-00001 |
| MDR Report Key | 316359 |
| Report Source | 06 |
| Date Received | 2001-02-14 |
| Date of Report | 2001-02-14 |
| Date of Event | 2000-11-27 |
| Date Mfgr Received | 2000-11-27 |
| Date Added to Maude | 2001-02-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD. |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878279 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KC BASIC XTRA TRACTION SHOE COVER |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2001-02-14 |
| Model Number | NA |
| Catalog Number | 69352 |
| Lot Number | 09500FW23:50 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 305912 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD. ROSWELL GA 30076 US |
| Baseline Brand Name | KC BASIC XTRA TRACTION SHOE COVER |
| Baseline Generic Name | SHOE COVER |
| Baseline Model No | NA |
| Baseline Catalog No | 69352 |
| Baseline ID | NA |
| Baseline Device Family | SHOE COVER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K880384 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-02-14 |