MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-04 for SEAL RITE MASK WITH ONE-WAY VALVE 120 manufactured by The Lifeguard Store, Inc..
[4505011]
I became aware of a defect in the design or manufacturing of a disposable resuscitation mask for water rescue just by happenstance. It was reported on the manufacturer's website to rupture when impacting on the water. Since it is a disposable, there is no way to test the device before use. Failure of a resuscitation mask could be life threatening. I happened to see the product recall on the manufacturers website during a random visit to the website but did not receive a notification after i had purchased one. I did not find the product listed on the fda website and i am not certain if it or its associated rescue breathing valve are fda approved. Since i did not receive a notification of the recall and could not find it on the fda website, i was concerned that other purchasers might not be aware of the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036511 |
| MDR Report Key | 3866759 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-06-03 |
| Date Added to Maude | 2014-06-12 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL RITE MASK WITH ONE-WAY VALVE |
| Generic Name | MASK WITH ONE - WAY VALVE |
| Product Code | BSJ |
| Date Received | 2014-06-04 |
| Model Number | 120 |
| Catalog Number | 120 |
| Lot Number | 14015 |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE LIFEGUARD STORE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |