MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for SIMILAC INFANT NIPPLE & RING 88075SG00 manufactured by Abbott Laboratories.
[115101213]
Rn who was feeding baby noticed that he took his po volume faster than the previous care times. After 30 mls had been nippled, rn removed the nipple from the baby's mouth to burp at which time she noticed the nipple was missing a chunk out of the side of it. The baby did not choke or desat while eating. The missing piece of the nipple was unable to be found. Photograph attached to this report. ====================== manufacturer response for infant nipple and ring, similac infant nipple & ring (per site reporter). ====================== spoke to manufacturer who advises that they will be sending a box to send the device back in. They did ask that i also send an unopened device along with the defective device back for laboratory comparison.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7721917 |
| MDR Report Key | 7721917 |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-07-14 |
| Report Date | 2018-07-20 |
| Date Reported to FDA | 2018-07-20 |
| Date Reported to Mfgr | 2018-07-26 |
| Date Added to Maude | 2018-07-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 INFANT NIPPLE & RING |
| Generic Name | NIPPLE, LAMBS FEEDING |
| Product Code | FNN |
| Date Received | 2018-07-26 |
| Model Number | 88075SG00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064 US 60064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-26 |