MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-29 for * manufactured by Cardinal Health, V. Mueller Division.
[20688765]
Sternal strut explanted in 2005 due to fracture of strut. Remains symptomac with shortness of breath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 597473 |
| MDR Report Key | 597473 |
| Date Received | 2005-04-29 |
| Date of Report | 2005-04-22 |
| Date of Event | 2005-04-15 |
| Date Facility Aware | 2005-04-15 |
| Report Date | 2005-04-22 |
| Date Reported to Mfgr | 2005-04-22 |
| Date Added to Maude | 2005-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | STERNAL STRUCT |
| Product Code | IQO |
| Date Received | 2005-04-29 |
| Returned To Mfg | 2004-04-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | INSTRUMENT # CH 696-020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 587301 |
| Manufacturer | CARDINAL HEALTH, V. MUELLER DIVISION |
| Manufacturer Address | 1430 WAUKEGAN ROAD B2-2 MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-04-29 |