MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-05 for EXPA-SYL manufactured by .
[2561074]
On (b)(6) 2004, the patient came into the doctor's office for a root canal. A pre-fabricated post and core were cemented then the tooth was prepared for a temporary crown using expa-syl. Immediately, a reaction to the product occurred which included red, irritated gums that sloughed off. The product was rinsed off and the temporary crown was placed with the margins exposed to prevent further irritation. It was noted during a check-up on (b)(6) 2004 that the gums were still very irritated, red and puffy. Due to the condition of the area cementing of the permanent crown was delayed by the doctor. A check-up on (b)(6) 2004 revealed the area to be partially healed, but the patient reported daily pain. Penicillin and gelclair, a mouth rinse for sores, were prescribed. In a (b)(6) 2004 check-up the tooth was found to be very mobile. The gum resorbed on the facial and there was significant bone loss. On (b)(6) 2004 the tooth was extracted and a bridge on teeth 10-12 was placed. Route used: (b)(6). Diagnosis for use: hemostatic agent/gingival retraction paste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003677417-2004-00001 |
| MDR Report Key | 2437756 |
| Date Received | 2004-10-05 |
| Date of Report | 2004-09-24 |
| Date of Event | 2004-06-24 |
| Date Added to Maude | 2012-02-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | ZI DU PHARE 17, AV GUSTAVE EIFFEL |
| Manufacturer City | MERIGNAC CEDEX |
| Manufacturer Country | FR |
| Manufacturer G1 | PRODUITS DENTAIRES PIERRE ROLLAND |
| Manufacturer Street | ZI DU PHARE 17, AV GUSTAVE EIFFEL |
| Manufacturer City | MERIGNAC CEDEX |
| Manufacturer Country | FR |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPA-SYL |
| Generic Name | RETRACTION CORD MVL |
| Product Code | MVL |
| Date Received | 2004-10-05 |
| Lot Number | UNK |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-05 |