MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-31 for JOLLYPOP PACIFIER manufactured by Sandbox Medical Llc.
[20749012]
Hospital staff were contacted by mother of infant born in (b)(6) 2014. She claims her infant sucked the end off of a jollypop pacifier that was given to her while she was a pt here. Supposedly the mother needed to retrieve the end piece from the baby's mouth before it was swallowed. She claims this was the second time a tip came off of a pacifier manufactured by this company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041876 |
| MDR Report Key | 4664611 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-27 |
| Date Added to Maude | 2015-04-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 | JOLLYPOP PACIFIER |
| Generic Name | BABY PACIFIER |
| Product Code | LQX |
| Date Received | 2015-03-31 |
| Lot Number | JP 1303 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANDBOX MEDICAL LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-31 |