MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-28 for MANM PACIFIER 160561 manufactured by Sassy, Inc..
[12483]
The child placed the device in his mouth. The sitter came into the room to check on the child & noticed that the entire pacifier was lodged in the back of the mouth. Child had an obstructed pathway. The sitter attempted to finger sweep without success. The child was moving some air. The airway was partially obstructed, so sitter put the child in the car & went to the er. When the child arrived at the hosp he was moving air. Movement could be heard with his breathing. Upon visual exam, the foreign body could be seen in the posterior oropharnyx. It took approx 5-7 minutes to extract the device. It was wedged so tightly in the throat that the hcp created a lot of trauma to remove it. Resuscitation wasx successful & the child was hospitalized for potential swelling after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006788 |
| MDR Report Key | 24978 |
| Date Received | 1995-08-28 |
| Date of Report | 1995-08-24 |
| Date of Event | 1995-08-24 |
| Date Added to Maude | 1995-08-28 |
| 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 | 0 |
| 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 | MANM PACIFIER |
| Generic Name | PACIFIER |
| Product Code | KBN |
| Date Received | 1995-08-28 |
| Model Number | 160561 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25416 |
| Manufacturer | SASSY, INC. |
| Manufacturer Address | GRAND RAPIDS MI 49507 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1995-08-28 |