MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for SIMILAC SLOW FLOW NIPPLE AND RING manufactured by Abbott Nutrition Abbott Laboratories.
[82599268]
Patient Sequence No: 1, Text Type: N, H10
[82599269]
Infant's father noticed discoloration in nipple, prior to bottle feeding infant. Appears to be consistent with metal shard. Infant's father brought nipple to nursing staff and it was not used with infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6791557 |
| MDR Report Key | 6791557 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-08-02 |
| Report Date | 2017-08-03 |
| Date Reported to FDA | 2017-08-03 |
| Date Reported to Mfgr | 2017-08-03 |
| Date Added to Maude | 2017-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | SIMILAC SLOW FLOW NIPPLE AND RING |
| Generic Name | NIPPLE, LAMBS FEEDING |
| Product Code | FNN |
| Date Received | 2017-08-14 |
| Lot Number | 77071SG00 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT NUTRITION ABBOTT LABORATORIES |
| Manufacturer Address | 100 SOUTH SAUNDERS ROAD LAKE FOREST IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |