MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-31 for SIMILAC INFANT NIPPLE AND RING UNK manufactured by Ross Products Division Abbott Laboratories.
[74344]
During bottle feeding, after infant sucked on nipple several times, noted expressed breast milk running down chin. When withdrew nipple, from infant's mouth, noted top of nipple was missing. Unable to locate nipple. Device is nonradiopaque; therefore, facility is unable to determine if the infant swallowed the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 144738 |
| MDR Report Key | 144738 |
| Date Received | 1997-12-31 |
| Date of Report | 1997-12-15 |
| Date of Event | 1997-12-03 |
| Date Facility Aware | 1997-12-03 |
| Report Date | 1997-12-15 |
| Date Added to Maude | 1998-01-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SIMILAC INFANT NIPPLE AND RING |
| Generic Name | NIPPLE |
| Product Code | FNN |
| Date Received | 1997-12-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 141122 |
| Manufacturer | ROSS PRODUCTS DIVISION ABBOTT LABORATORIES |
| Manufacturer Address | 625 CLEVELAND AVE. COLUMBUS OH 43216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-31 |