MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-29 for AUTOMATED CO2 COLON INSUFFLATOR 390301 manufactured by Bracco Diagnostics.
[5910552]
Air cuff burst in pt's rectum while performing ct colonography. Diagnosis or reason for use: virtual colonoscopy via ct scan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042936 |
| MDR Report Key | 4824975 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-14 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATED CO2 COLON INSUFFLATOR |
| Generic Name | CT COLONOSCOPY INFUSSLATION DEVICE |
| Product Code | FCX |
| Date Received | 2015-05-29 |
| Catalog Number | 390301 |
| Lot Number | 50865994 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTICS |
| Manufacturer Address | MONROE TOWNSHIP NJ 08831 US 08831 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-29 |