MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-11 for REGULAR SIMILAC NIPPLE manufactured by .
[3985225]
Infant bottle feeding with regular (b)(6) nipple. The feeding was not flowing out and no bubbles noted in bottle; nipple changed and checked, and feeding did flow out manually. After 10 minutes, the feeding stopped coming out and no bubbles noted in bottle. Nipple changed again with a nipple from different batch number; and milk able to flow out, bubbles noted in bottle, and infant finished feeding in less than 10 minutes. Other nipples checked manually from same batch, and same thing happened; the liquid would start to flow but then stop. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034548 |
| MDR Report Key | 3636690 |
| Date Received | 2014-02-11 |
| Date of Report | 2014-02-10 |
| Date of Event | 2014-02-07 |
| Date Added to Maude | 2014-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REGULAR SIMILAC NIPPLE |
| Generic Name | REGULAR SIMILAC NIPPLE |
| Product Code | FNN |
| Date Received | 2014-02-11 |
| Lot Number | 34162SG |
| Device Expiration Date | 2016-11-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-11 |