MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for SIMILAC SLOW FLOW NIPPLE AND RING manufactured by Abbott Nutrition.
[142893224]
Mother fed baby with brand new, similac, slow flow nipple. Mother noticed baby struggling with feed. Mother noted very large, off center hole in nipple.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8543519 |
| MDR Report Key | 8543519 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-05 |
| Report Date | 2019-04-09 |
| Date Reported to FDA | 2019-04-09 |
| Date Reported to Mfgr | 2019-04-24 |
| Date Added to Maude | 2019-04-24 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Generic Name | SIMILAC SLOW FLOW NIPPLE AND RING |
| Product Code | FNN |
| Date Received | 2019-04-24 |
| Lot Number | 95194SG00 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT NUTRITION |
| Manufacturer Address | 585 CLEVELAND AVE COLUMBUS OH 43215 US 43215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |