MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-04-12 for EXPA-SYL 34620 manufactured by Produits Dentaires Pierre Rolland.
[2621994]
A doctor alleged that within the past year, approximately five (5) patients have had possible reactions in the form of inflammation and swollen gums to exapsyl (strawberry). All patients required antibiotic for treatment. This is the fifth of five reports.
Patient Sequence No: 1, Text Type: D, B5
[19844453]
This is a follow-up report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1815757-2012-00007 |
| MDR Report Key | 2534252 |
| Report Source | * |
| Date Received | 2012-04-12 |
| Date of Report | 2012-03-13 |
| Date Facility Aware | 2012-03-13 |
| Report Date | 2012-06-14 |
| Date Reported to FDA | 2012-06-14 |
| Date Reported to Mfgr | 2012-06-14 |
| Date Added to Maude | 2012-04-12 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| 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 | RETRACTION CORD |
| Product Code | MVL |
| Date Received | 2012-04-12 |
| Catalog Number | 34620 |
| Lot Number | 3727 |
| Device Expiration Date | 2013-05-01 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-04-12 |