MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2003-10-09 for BASIC X-TRA TRACTION SHOE COVER, UNIVERSAL 69352 manufactured by Kimberly-clark Corp..
[302767]
A nurse fell while wearing damp shoe covers and bruised and lacerated their jaw and sustained a chipped tooth. Reportedly received a hairline fracture of the jaw. The individual was seen in the er by a dentist. No hospitalization was required nor was surgery required. The shoe covers were damp from being in a surgery room where the floor was wet. The floor had recently been polished and was dry where the fall occurred. Kimberly-clark corp has no first hand knowledge of the allegations, but is relaying information received from outside source pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003880811-2003-00001 |
| MDR Report Key | 488672 |
| Report Source | 06,07 |
| Date Received | 2003-10-09 |
| Date of Report | 2003-10-09 |
| Date of Event | 2003-09-10 |
| Date Mfgr Received | 2003-09-15 |
| Date Added to Maude | 2003-10-15 |
| 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 ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878279 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION |
| Manufacturer Street | 6625 INDUSTRIAL PARK BLVD |
| Manufacturer City | N. RICHLAND HILLS TX 76180 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76180 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASIC X-TRA TRACTION SHOE COVER, UNIVERSAL |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2003-10-09 |
| Model Number | NA |
| Catalog Number | 69352 |
| Lot Number | 20403FW13:01 |
| 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 | 477491 |
| 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 | 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 | 2003-10-09 |