MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-19 for MINI-MAN PACIFIER NA manufactured by Sassy, Inc..
[38106]
Pacifier placed in mouth of crying newborn found in pieces when nurse returned to crib. Came apart into 3 small pieces, any of which were small enough to present an aspiration hazard to a newborn. No actual pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 58218 |
| MDR Report Key | 58218 |
| Date Received | 1996-12-19 |
| Date of Report | 1996-12-17 |
| Date of Event | 1996-11-07 |
| Date Facility Aware | 1996-12-10 |
| Report Date | 1996-12-17 |
| Date Reported to FDA | 1996-12-17 |
| Date Added to Maude | 1996-12-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI-MAN PACIFIER |
| Generic Name | PACIFIER |
| Product Code | LQX |
| Date Received | 1996-12-19 |
| Returned To Mfg | 1996-12-17 |
| Model Number | MINI-MAN |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58697 |
| Manufacturer | SASSY, INC. |
| Manufacturer Address | 633 SKOKIE BLVD GRAND RAPIDS MI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-19 |