MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for SIMILAC INFANT NIPPLE AND RING manufactured by Abbott Nutrition.
[97002340]
Mom was feeding newborn with a bottle and prior to feeding she noted a small metallic shard embedded in the nipple part of the bottle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074486 |
| MDR Report Key | 7178835 |
| Date Received | 2018-01-09 |
| Date of Report | 2018-01-08 |
| Date of Event | 2018-01-06 |
| Date Added to Maude | 2018-01-10 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIMILAC INFANT NIPPLE AND RING |
| Generic Name | NIPPLE, LAMBS FEEDING |
| Product Code | FNN |
| Date Received | 2018-01-09 |
| Lot Number | 82142SG00 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT NUTRITION |
| Manufacturer Address | COLUMBUS OH 43219 US 43219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-09 |