MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 1999-08-20 for SARA POWER KKBXXXX KKA0630 manufactured by Arjo Ltd.
[184431]
Pt caught his hand in the operating of parachute hook on sara power lift. Pt sustained injury to his wrist requiring stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617021-1999-00033 |
| MDR Report Key | 236967 |
| Report Source | 01,06,07 |
| Date Received | 1999-08-20 |
| Date of Report | 1999-08-13 |
| Date of Event | 1999-05-26 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1999-08-26 |
| 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 Contact | STEPHANIE WRIGHT |
| Manufacturer Street | 50 N. GARY AVE |
| Manufacturer City | ROSELLE IL 60620 |
| Manufacturer Country | US |
| Manufacturer Postal | 60620 |
| Manufacturer Phone | 6303076140 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA POWER |
| Generic Name | PATIENT LIFT |
| Product Code | FWG |
| Date Received | 1999-08-20 |
| Model Number | KKBXXXX |
| Catalog Number | KKA0630 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229645 |
| Manufacturer | ARJO LTD |
| Manufacturer Address | ST. CATHERINE ST GLOUCESTER, ENGLAND UK GL1 2SL |
| Baseline Brand Name | SARA POWER |
| Baseline Generic Name | PT LIFT |
| Baseline Model No | KKBXXXX |
| Baseline Catalog No | KKA0630 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-20 |