MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-05-14 for AIRCON XL 3000 AIR CONTRAST KIT 3L * 124072 manufactured by Mallinckrodt Lafayette.
[21705499]
Patient was having a standard barium enema when patient was rolled onto the side, putting more pressure on the retention cuff. It burst, the patient described the feeling as "having a rubber band popped inside". Examination of the rectum by a radiologist and a surgeon did not reveal any injuries. Patient recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1827430-2003-00001 |
| MDR Report Key | 465843 |
| Report Source | 05,06 |
| Date Received | 2003-05-14 |
| Date of Report | 2003-04-17 |
| Date of Event | 2003-04-17 |
| Date Mfgr Received | 2003-04-17 |
| Date Added to Maude | 2003-06-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MAX MYERS |
| Manufacturer Street | 526 N EARL |
| Manufacturer City | LAFAYETTE IN 47904 |
| Manufacturer Country | US |
| Manufacturer Postal | 47904 |
| Manufacturer Phone | 7654473129 |
| 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 | * |
| Product Code | FCE |
| Date Received | 2003-05-14 |
| Model Number | * |
| Catalog Number | 124072 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT LAFAYETTE |
| Manufacturer Address | 526 N. EARL LAFAYETTE IN 47904 US 47904 |
| Baseline Brand Name | AIRCON XL 3000 AIR CONTRAST KIT 3L |
| Baseline Generic Name | * |
| Baseline Model No | * |
| Baseline Catalog No | 124072 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-14 |