MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-01-20 for HYDROSIL 625340 manufactured by *.
[416992]
A pt claims to have developed a rash, pimples, burning sensations, and later sores/lesions on the face in the area where hydrosil xt contacted the skin during an impression procedure. The pt noted the symptoms began to develop a short time after the procedure and had been present for approx ten months at the time the event was reported. Two doctors were consulted and the pt was administered antibiotics, steroids, and a burn cream to treat the symptoms. Additionally, a biopsy was performed on the area and the symptoms classified as a "chemical/sun irritation reaction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2005-00540 |
| MDR Report Key | 666024 |
| Report Source | 00 |
| Date Received | 2006-01-20 |
| Date of Report | 2005-12-23 |
| Date of Event | 2005-02-15 |
| Date Mfgr Received | 2005-12-23 |
| Date Added to Maude | 2006-01-24 |
| 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 |
| 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 SUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY 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 | HYDROSIL |
| Generic Name | * |
| Product Code | EBH |
| Date Received | 2006-01-20 |
| Model Number | NA |
| Catalog Number | 625340 |
| 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 | 655395 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | HYDROSIL |
| Baseline Generic Name | * |
| Baseline Model No | NA |
| Baseline Catalog No | 625340 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-20 |