MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-11-22 for XTRA TRACTION SHOE COVER 69252 manufactured by Kimberly-clark Corp.
[183445]
A hospital employee slipped, fell and hit her head while wearing the shoecovers which resulted in a concussion. The employee was treated in the hospital's er and released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044184-1999-00006 |
| MDR Report Key | 251490 |
| Report Source | 07 |
| Date Received | 1999-11-22 |
| Date of Report | 1999-11-18 |
| Date of Event | 1999-08-01 |
| Date Mfgr Received | 1999-08-04 |
| Date Added to Maude | 1999-11-30 |
| 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 | 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 | MAQUILLAS TETA-KAWI, SA DE CV |
| Manufacturer Street | * |
| Manufacturer City | EMPALME, SONORA MEXICO * * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| 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 | 1999-11-22 |
| Returned To Mfg | 1999-08-19 |
| Model Number | NA |
| Catalog Number | 69252 |
| Lot Number | 1549FA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 243630 |
| Manufacturer | KIMBERLY-CLARK CORP |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US |
| Baseline Brand Name | XTRA TRACTION SHOE COVER |
| Baseline Generic Name | SHOE COVER |
| Baseline Model No | NA |
| Baseline Catalog No | 69252 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-11-22 |