MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-07 for SP ORANGE 50GM GLUCOSE TOLERANCE BEVERAGE * B5395-7A manufactured by Cardinal Health.
[20920152]
Patient was given an orange glucose tolerance beverage 50gm. Patient consumed the mixture and noticed that there was blood in her mouth and felt a piece of glass. Bottle examined by patient for breakage - none found. Patient placed glass in bottle and returned it to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031863 |
| MDR Report Key | 1031863 |
| Date Received | 2008-04-07 |
| Date of Report | 2008-04-07 |
| Date of Event | 2008-03-31 |
| Report Date | 2008-04-07 |
| Date Reported to FDA | 2008-04-07 |
| Date Added to Maude | 2008-04-23 |
| 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 |
| 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 | SP ORANGE 50GM GLUCOSE TOLERANCE BEVERAGE |
| Generic Name | ORANGE GLUCOSE TOLERANCE BEVERAGE |
| Product Code | MRV |
| Date Received | 2008-04-07 |
| Model Number | * |
| Catalog Number | B5395-7A |
| Lot Number | 4067 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 998992 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN ROAD MCGAW PARK IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-07 |