MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2005-02-23 for RICH-MAR HLE-1000 * manufactured by *.
[15038233]
Treatment table was in use in pt department treating pt for neck injury. Therapist was adjusting table height and the head of the table dropped. Pt immediately complained of increased neck pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1623423-2005-00001 |
| MDR Report Key | 579266 |
| Report Source | 00,05,06 |
| Date Received | 2005-02-23 |
| Date of Report | 2005-02-22 |
| Date of Event | 2005-02-17 |
| Date Mfgr Received | 2005-02-17 |
| Date Added to Maude | 2005-03-10 |
| 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 | DAVID RICHARDS, VP & DIR |
| Manufacturer Street | PO BOX 879 |
| Manufacturer City | INOLA OK 74036 |
| Manufacturer Country | US |
| Manufacturer Postal | 74036 |
| Manufacturer Phone | 9185432222 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICH-MAR |
| Generic Name | HI-LO TREATMENT TABLE |
| Product Code | JFB |
| Date Received | 2005-02-23 |
| Model Number | HLE-1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 569114 |
| Manufacturer | * |
| Manufacturer Address | P.O. BOX 879 INOLA OK 74036 US |
| Baseline Brand Name | RICH-MAR |
| Baseline Generic Name | HI-LO TREATMENT TABLE |
| Baseline Model No | HLE-1000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-23 |