MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-12-09 for BUTLER PROPHY PASTE 1220B manufactured by Sunstar Americas, Inc..
[33076982]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33076983]
The child went to the dentist's office for a cleaning. The dentist indicated that sunstar's butler prophy paste (bubblegum fine) was used during the cleaning. The child was hospitalized the next day with a severe allergic reaction. It is unknown if it was the prophy paste the child reacted to or if it was one of the other products used during the cleaning appointment. The child has several known allergies. Several follow up calls have been made to determine the other products used at the child's appointment. The dentist confirmed the only sunstar product was the prophy paste. The other products have yet not been divulged, except that sealants were applied during this visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001413787-2015-00002 |
| MDR Report Key | 5278641 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-09 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2015-11-18 |
| Date Added to Maude | 2015-12-09 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG BELAIR |
| Manufacturer Street | 301 EAST CENTRAL ROAD |
| Manufacturer City | SCHAUMBURG IL 60195 |
| Manufacturer Country | US |
| Manufacturer Postal | 60195 |
| Manufacturer Phone | 8477944241 |
| Manufacturer G1 | SUNSTAR AMERICAS, INC. |
| Manufacturer Street | 301 EAST CENTRAL ROAD |
| Manufacturer City | SCHAUMBURG IL 60195 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60195 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUTLER PROPHY PASTE |
| Generic Name | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
| Product Code | EJR |
| Date Received | 2015-12-09 |
| Model Number | 1220B |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNSTAR AMERICAS, INC. |
| Manufacturer Address | 301 EAST CENTRAL ROAD SCHAUMBURG IL 60195 US 60195 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-09 |