MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-13 for SIMILAC INFANT NIPPLE AND RING #079 * manufactured by Ross Products Division Abbott Labs.
[89399]
Pt discharged from neonatal intensive care and given formula and nipples for home use. Parents discovered a foreign body in the nipple (metal? ) called hosp and brought the nipples back. The product was replaced with no known pt sequelae from this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011878 |
| MDR Report Key | 112950 |
| Date Received | 1997-08-13 |
| Date of Report | 1997-08-13 |
| Date of Event | 1997-07-11 |
| Date Added to Maude | 1997-08-18 |
| 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 |
| 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 | SIMILAC INFANT NIPPLE AND RING |
| Generic Name | SIMILAC INFANT NIPPLE AND RING |
| Product Code | FNN |
| Date Received | 1997-08-13 |
| Model Number | #079 |
| Catalog Number | * |
| Lot Number | 151865950 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 110868 |
| Manufacturer | ROSS PRODUCTS DIVISION ABBOTT LABS |
| Manufacturer Address | 625 CLEVELAND AVE. COLUMBUS OH 43218 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-13 |