MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-19 for SIMILAC manufactured by Abbott Nutrition Abbott Laboratories.
[3718381]
Staff opened package, inspected nipple prior to placing nipple on bottle for feeding and noted presence of what they described as "a bug. " all nipples with date (b)(4) 2016 and number (b)(4) were removed from nursery to be returned to company representative and replaced. The product being reported on was returned to company representative on friday, (b)(4) 2013. The nipple was not used on a baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3365255 |
| MDR Report Key | 3365255 |
| Date Received | 2013-09-19 |
| Date of Report | 2013-09-13 |
| Date of Event | 2013-08-31 |
| Date Facility Aware | 2013-09-04 |
| Report Date | 2013-09-13 |
| Date Reported to FDA | 2013-09-13 |
| Date Reported to Mfgr | 2013-09-13 |
| Date Added to Maude | 2013-09-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMILAC |
| Generic Name | INFANT NIPPLE AND RING |
| Product Code | FNN |
| Date Received | 2013-09-19 |
| Returned To Mfg | 2013-09-06 |
| Lot Number | 30105SG |
| Device Expiration Date | 2016-07-01 |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT NUTRITION ABBOTT LABORATORIES |
| Manufacturer Address | COLUMBUS OH 43219303 US 43219 3034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-19 |