MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2009-05-28 for EXPA-SYL 31172 manufactured by Produits Dentaires Pierre Rolland.
[1129957]
On (b) (6) 2009, the patient reported that he went to his dentist on (b) (6) for a routine crown seating and that after his dentist applied expa-syl, he immediately experienced an allergic reaction with burning and shortness of breath. An ambulance was called and the patient was taken to the emergency room for treatment with iv, benadryl and epinephrine. The reaction gradually resolved and after two hours the patient was discharged and by that afternoon the patient reported that he felt fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1815757-2009-00001 |
| MDR Report Key | 1394361 |
| Report Source | * |
| Date Received | 2009-05-28 |
| Date of Report | 2009-04-30 |
| Date of Event | 2009-04-23 |
| Date Facility Aware | 2009-04-30 |
| Report Date | 2009-05-28 |
| Date Reported to FDA | 2009-05-28 |
| Date Reported to Mfgr | 2009-05-28 |
| Date Added to Maude | 2010-03-02 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPA-SYL |
| Generic Name | CORD, RETRACTION |
| Product Code | MVL |
| Date Received | 2009-05-28 |
| Catalog Number | 31172 |
| Lot Number | 1599 |
| Device Expiration Date | 2010-12-31 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUITS DENTAIRES PIERRE ROLLAND |
| Manufacturer Address | ZI DU PHARE 17, AVE GUSTAVE EIFFEL BP 216 MERIGNAC CEDEX, 33708 FR 33708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-05-28 |