MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for WNL PRODUCTS PRACTI VALVES CPR SHIELD manufactured by .
[68755355]
May daughter was using the practi-valves that are used to practice mouth-to-mouth resuscitation/cpr in high school health class. The end-cap of the valve detached during training and she swallowed the end cap. Incident location: school - (b)(6). Injury info: injury, emergency department treatment received. (b)(4). Product description: blue plastic air valve, places it over the dummy's mouth and blows through the valve to fill the dummy's lungs with air. "(b)(4)" is printed in white on the valves. The valves measure 2. 75 inches long by 1 inch wide and are disposable. (b)(4). Product category: practi-valves-this recall involves practi-valves that are used to practice mouth-to-mouth resuscitation/cpr. The trainee connects the blue plastic air valve to plastic mask, places it over the dummy's mouth and blows through the valve to fill the dummy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068173 |
| MDR Report Key | 6364038 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-02-13 |
| Date Added to Maude | 2017-02-28 |
| 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 | WNL PRODUCTS PRACTI VALVES CPR SHIELD |
| Generic Name | WNL PRODUCTS PRACTI VALVES CPR SHIELD |
| Product Code | CBP |
| Date Received | 2017-02-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |