MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-07-14 for * manufactured by Ohio Medical Instrument Co., Inc..
| Report Number | 1525725-2003-00030 |
| MDR Report Key | 472338 |
| Report Source | 05,06 |
| Date Received | 2003-07-14 |
| Date of Event | 2003-06-24 |
| Date Mfgr Received | 2003-06-12 |
| Date Added to Maude | 2003-07-21 |
| 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 | W WEBBER |
| Manufacturer Street | 4900 CHARLEMAR DR |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal | 45227 |
| Manufacturer Phone | 5135612241 |
| Manufacturer G1 | OHIO MEDICAL INSTRUMENT CO INC. |
| Manufacturer Street | 4900 CHARLEMAR DR |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HBM |
| Date Received | 2003-07-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 461191 |
| Manufacturer | OHIO MEDICAL INSTRUMENT CO., INC. |
| Manufacturer Address | 4900 CHARLEMAR DR. CINCINNATI OH 45227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-14 |