MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-03-17 for AQUASIL ULTRA UNK manufactured by Dentsply Caulk.
[21628045]
A pt experienced numbing and tingling sensations and later swelling and scalloping of the tongue with lesions after multiple impressions with aquasil ultra monophase and aquasil easy mix putty, indicating a possible allergic reaction to either material or a constituent part. The symptoms resolved without medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2005-00070 |
| MDR Report Key | 582328 |
| Report Source | 05,07 |
| Date Received | 2005-03-17 |
| Date of Report | 2005-02-15 |
| Date Mfgr Received | 2005-02-15 |
| Date Added to Maude | 2005-03-18 |
| 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 | 0 |
| Manufacturer Contact | DR PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST. STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLLY CAULK |
| Manufacturer Street | 38 W. CLARKE AVE |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUASIL ULTRA |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | EBH |
| Date Received | 2005-03-17 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 572170 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | * MILFORD DE * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-17 |