MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-07 for NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER * manufactured by Mead Johnson Nutritionals.
[354195]
The pt was discovered to have a finger caught in the vent hole of a mead johnson nutritionals nuk newborn orthodontic pacifier-exerciser. The finger had swelled and changed color, and there was difficulty in removing the finger due to the rigid plastic. Blood flow returned to the finger, and the swelling and color change resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032045 |
| MDR Report Key | 526483 |
| Date Received | 2004-05-07 |
| Date of Report | 2004-05-07 |
| Date of Event | 2004-05-07 |
| Date Added to Maude | 2004-05-26 |
| 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 |
| 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 | NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER |
| Generic Name | NEWBORN ORTHODONTIC PACIFIER-EXERCISER |
| Product Code | LQX |
| Date Received | 2004-05-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515650 |
| Manufacturer | MEAD JOHNSON NUTRITIONALS |
| Manufacturer Address | * EVANSVILLE IN 47721 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-05-07 |