MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for SUPER DROPPER 70005 manufactured by .
[52503653]
Customer called in and advised that he has some droppers that the packaging says 2tsp capacity, but the dropper itself only has the capacity of 1tsp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182780-2016-00011 |
| MDR Report Key | 5854910 |
| Date Received | 2016-08-08 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-07-14 |
| Date Added to Maude | 2016-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAYCEE NICHOLS |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS OH 44130 |
| Manufacturer Country | US |
| Manufacturer Postal | 44130 |
| Manufacturer Phone | 8009471728 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPER DROPPER |
| Generic Name | DROPPER |
| Product Code | KCM |
| Date Received | 2016-08-08 |
| Model Number | 70005 |
| Catalog Number | 70005 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-08 |