MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for MI PASTE manufactured by Gc Corp..
[27311167]
Gc america received a report on 08/24/2015 from (b)(4), from a sales representative that mi paste was applied to a patient with milk allergies. The report stated that prior to treatment, the parent reported that the patient had an allergy to milk, but the product was still applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2015-00004 |
| MDR Report Key | 5117881 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-08-19 |
| Date Facility Aware | 2015-09-03 |
| Report Date | 2015-09-17 |
| Date Added to Maude | 2015-10-01 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer G1 | GC AMERICA, INC. |
| Manufacturer Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MI PASTE |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2015-09-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORP. |
| Manufacturer Address | 76-1 HASUNUMA-CHO ITABASHI-KU, TOKYO 174 JA 174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-22 |