MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-05-16 for AIRCON XL 3000 AIR CONTRAST KIT 3L 124072 manufactured by Covidien.
[18513886]
Customer reports via phone: retention balloon prepped once, then positioned. The retention balloon was given one squeeze on the white pillow. Retention cuff burst. Second retention cuff system was then prepped once. Positioned. Retention cuff given 1 and 1/2 squeezes on the white pillow. The retention cuff burst.
Patient Sequence No: 1, Text Type: D, B5
[18722854]
Root cause identified: no product sample was not received, therefore no investigation could be carried out. Conclusions: there is no previous complaint to this assembly part number. Corrective actions: no formal corrective actions were assigned due to lack of physical sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2008-00015 |
| MDR Report Key | 1051370 |
| Report Source | 06 |
| Date Received | 2008-05-16 |
| Date of Report | 2005-05-19 |
| Date Mfgr Received | 2005-05-19 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2010-04-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BANSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD LIBRIAMENTO A LA P., LA MESA |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| 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 | BARIUM ENEMA TIP |
| Product Code | FCE |
| Date Received | 2008-05-16 |
| Model Number | AIR CONTRAST KIT |
| Catalog Number | 124072 |
| Lot Number | 4264119 |
| ID Number | NA |
| Device Expiration Date | 2007-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-16 |