MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-11-12 for AIRCON XL 3000 AIR CONTRAST KIT 3L * 124072 manufactured by Nellcor/tyco Healthcare.
[19780154]
Sometime last week, a routine barium enema was performed on a pt. The retension cuff was blown up and sometime during the procedure, broke while in the pt. The balloon was still attached to the tip and was removed. The pt suffered no adverse effect from this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-2003-00001 |
| MDR Report Key | 496365 |
| Report Source | 05,06 |
| Date Received | 2003-11-12 |
| Date of Report | 2003-11-11 |
| Date Mfgr Received | 2003-11-11 |
| Date Added to Maude | 2003-11-20 |
| 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 | IRMA SANTIAGO |
| Manufacturer Street | 2660 SARNEN ST STE 220 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal | 92154 |
| Manufacturer Phone | 6196615100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCON XL 3000 AIR CONTRAST KIT 3L |
| Generic Name | ENEMA KIT W/ SILICONE RETENTION CUFF |
| Product Code | FCE |
| Date Received | 2003-11-12 |
| Model Number | * |
| Catalog Number | 124072 |
| Lot Number | 3195060 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485098 |
| Manufacturer | NELLCOR/TYCO HEALTHCARE |
| Manufacturer Address | 2660 SARNEN ST. STE 220 SAN DIEGO CA 92154 US |
| Baseline Brand Name | AIRCON XL 3000 AIR CONTRAST KIT 3L |
| Baseline Generic Name | ENEMA KIT W/ SILICONE RETENTION CUFF |
| Baseline Model No | * |
| Baseline Catalog No | 124072 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-12 |