MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2005-07-12 for SARITA KKBXXXX KKA0401 manufactured by Arjo Med Ab Ltd..
[20922545]
The facility reports while being transferred from the wheelchair by means of the boist, the pt slipped up to their shoulders inthe sling and could not hold on. The center lowered the pt to the floor and did not move pt unitll the family doctor was called. Pt was in lots of pain. The pt was taken to the hosp where pt was diagnosed as having fractured hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617021-2005-00043 |
| MDR Report Key | 620645 |
| Report Source | 01 |
| Date Received | 2005-07-12 |
| Date of Report | 2005-07-12 |
| Date of Event | 2005-07-07 |
| Date Mfgr Received | 2005-07-07 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 2005-07-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TRACI GIOVENCO |
| Manufacturer Street | 501 N. GARY AVE. SUITE A |
| Manufacturer City | ROSEILE IL 60172 |
| Manufacturer Country | US |
| Manufacturer Postal | 60172 |
| Manufacturer Phone | 6303076140 |
| Manufacturer G1 | ARJO MED. AB LTD. |
| Manufacturer Street | ST. CATHERINE ST. |
| Manufacturer City | GLOUCESTER GL12SL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GL1 2SL |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARITA |
| Generic Name | PATIENT LIFT |
| Product Code | FWG |
| Date Received | 2005-07-12 |
| Model Number | KKBXXXX |
| Catalog Number | KKA0401 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 610331 |
| Manufacturer | ARJO MED AB LTD. |
| Manufacturer Address | * GLOUCESTER UK |
| 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 | 1. Required No Informationntervention | 2005-07-12 |