MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-04-24 for CHAMPION MFG 54 SERIES manufactured by Champion Mfg. Inc..
[20684428]
The letter from an attorney alleges the consumer's legs flipped off the chair and hit a bolt, causing a hematoma that required surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1834066-2006-00001 |
| MDR Report Key | 703857 |
| Report Source | 00 |
| Date Received | 2006-04-24 |
| Date of Report | 2006-04-18 |
| Date of Event | 2006-01-17 |
| Date Mfgr Received | 2006-03-21 |
| Date Added to Maude | 2006-04-27 |
| 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 | RON CLINES |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 4403263115 |
| Manufacturer G1 | CHAMPION MANUFACTURING INC |
| Manufacturer Street | 2601 INDUSTRIAL PKWY |
| Manufacturer City | ELKHART IN 46516 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMPION MFG |
| Generic Name | 880.6140 |
| Product Code | FIA |
| Date Received | 2006-04-24 |
| Model Number | 54 SERIES |
| Catalog Number | 54 SERIES |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 692958 |
| Manufacturer | CHAMPION MFG. INC. |
| Manufacturer Address | * ELKHART IN 46516 US |
| Baseline Brand Name | CHAMPION MFG |
| Baseline Generic Name | 880.6140 |
| Baseline Model No | 54 SERIES |
| Baseline Catalog No | 54 SERIES |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-24 |