MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-23 for OMI 550 550-001 manufactured by Ohio Medical Instrument Co..
[257052]
Patient was on stretcher lying on their side with the side rails up and locked. The patient was repositioning themself and leaned against the siderail. The siderail dropped and so did the patient landing on their head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525725-2002-00038 |
| MDR Report Key | 423879 |
| Report Source | 05,06 |
| Date Received | 2002-10-23 |
| Date of Report | 2002-09-18 |
| Date Facility Aware | 2002-09-17 |
| Report Date | 2002-09-18 |
| Date Reported to Mfgr | 2002-09-18 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2002-10-28 |
| 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 | 3 |
| Manufacturer Contact | W. WEBBER |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal | 45227 |
| Manufacturer Phone | 5135612241 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMI |
| Generic Name | STRETCHER |
| Product Code | INW |
| Date Received | 2002-10-23 |
| Model Number | 550 |
| Catalog Number | 550-001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 412930 |
| Manufacturer | OHIO MEDICAL INSTRUMENT CO. |
| Manufacturer Address | 4900 CHARLEMAR DR. CINCINNATI OH 45227 US |
| Baseline Brand Name | OHIO MEDICAL INSTRUMENT COMPANY, INC. 550 STRETCHER |
| Baseline Generic Name | MECHANICAL TABLE |
| Baseline Model No | 550 |
| Baseline Catalog No | K550-001 |
| Baseline Device Family | 550 STRETCHER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-10-23 |