MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for GUN DROP FULL TERM PACIFIER 204011N manufactured by Natus Medical Inc..
[66383794]
Pacifier was noted by mother of infant to have exposed hard plastic protruding through the device surface that cut the infants lips. Upon further evaluation, small pieces, approximately 2 to 4 mm of clear plastic were breaking off from the hard plastic. Dates of use: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067596 |
| MDR Report Key | 6294223 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-24 |
| Date of Event | 2017-01-20 |
| Date Added to Maude | 2017-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUN DROP FULL TERM PACIFIER |
| Generic Name | PACIFIER |
| Product Code | HCC |
| Date Received | 2017-01-24 |
| Catalog Number | 204011N |
| Lot Number | 003374A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-24 |