MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-06-30 for BASIC X-TRA TRACTION SHOE COVER 69352 manufactured by Kimberly-clark Corp.
[19950677]
A nurse put on a pair of shoe covers at approx 6:30 am as she routinely does when arriving at work. She did not notice any problems or defects with the shoe covers. While walking into the surgical suite, at approx 10:00am, she slipped and fell breaking her left radius (wrist). Her forearm was placed in a cast and she returned to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022573-1999-00002 |
| MDR Report Key | 230351 |
| Report Source | 07 |
| Date Received | 1999-06-30 |
| Date of Report | 1999-06-29 |
| Date of Event | 1999-05-19 |
| Date Mfgr Received | 1999-06-09 |
| Date Added to Maude | 1999-07-08 |
| 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 |
| 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 | 1999-06-30 |
| Model Number | NA |
| Catalog Number | 69352 |
| Lot Number | 0419N07:56 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 223390 |
| Manufacturer | KIMBERLY-CLARK CORP |
| Manufacturer Address | 1400 HOLCOMB BRDIGE RD 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 | 69352 |
| Baseline ID | NA |
| Baseline Device Family | SHOE COVER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864026 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-30 |