MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for SIMILAC VOLU-FEED 00180 manufactured by Abbott Nutrition Abbott Laboratories.
[79066459]
Patient Sequence No: 1, Text Type: N, H10
[79066460]
Infant's feeding and medications prepared in disposable nurser/bottle. Upon inverting bottle to feed infant, small amount of formula and medications leaked out small crack in nurser/bottle. Contents of nurser/bottle were placed into new nurser/bottle and fed without further incident. Affected nurser/bottle and another unopened package that appeared to have same issue were saved for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6686082 |
| MDR Report Key | 6686082 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-05-30 |
| Report Date | 2017-06-12 |
| Date Reported to FDA | 2017-06-12 |
| Date Reported to Mfgr | 2017-06-12 |
| Date Added to Maude | 2017-07-05 |
| 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 VOLU-FEED |
| Generic Name | NIPPLE, LAMBS FEEDING |
| Product Code | FNN |
| Date Received | 2017-07-05 |
| Returned To Mfg | 2017-06-02 |
| Model Number | 00180 |
| Lot Number | 76081LS00 094 04 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-07-05 |