MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for AEROBIKA manufactured by Trudell Medical Int'l.
[116088472]
The green valve of my child's aerobika came out and was lodged in her airway while she was using it. She was choking and fortunately was able to cough hard enough to get the part out. This part is large enough to completely block an airway and become deadly. This is not the first time we have had a problem with the valve in more than one aerobika. As a parent and a pediatric nurse, i find this very troubling and felt obligated to report this issue. This problem was reported to monaghan and they have sent replacements but they want the defective device back. I don't' know if i should give it to them or hold onto it for now. Monaghan medical corp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078849 |
| MDR Report Key | 7746714 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-07-22 |
| Date Added to Maude | 2018-08-03 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AEROBIKA |
| Generic Name | SPIROMETER, THERAPEUTIC (INCENTIVE) |
| Product Code | BWF |
| Date Received | 2018-08-02 |
| Lot Number | 180011 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUDELL MEDICAL INT'L |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-08-02 |