MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for PSA INFANTCARE * manufactured by Pediatric Services Of America, Inc..
[297691]
Reporter has family member who used psa moisturizer inhaler (issued in (2003). Four days later device backflowed and water entered pt's lungs. Pt was taken to emergency room of hospital. "had referred device. " an adjustment was needed to the respirator. Pt is doing fine, no need for respirator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003637 |
| MDR Report Key | 500924 |
| Date Received | 2003-11-24 |
| Date of Report | 2003-09-29 |
| Date of Event | 2003-09-29 |
| Date Added to Maude | 2003-12-16 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSA INFANTCARE |
| Generic Name | MOISTURIZER INHALER |
| Product Code | KCO |
| Date Received | 2003-11-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 489694 |
| Manufacturer | PEDIATRIC SERVICES OF AMERICA, INC. |
| Manufacturer Address | 2751 CURTISS STREET DOWNERS GROVE IL 605154002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-24 |