MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-08-07 for DETREY CONDITIONER 36 60615208 manufactured by Dentsply Detrey.
[1189747]
It was reported that during a procedure, a syringe of detrey conditioner 36 burst, causing the material to contact the patient's face and right eye, resulting in a chemical burn to the cornea and fornix conjunctivae inferior. The patient was treated at a hospital for six days and as of the report had impaired visual performance; 30% without glasses, 80% with glasses.
Patient Sequence No: 1, Text Type: D, B5
[8275325]
While there is no indication that the device involved malfunctioned in this case, this event resulted in a serious injury. Further, though the device involved is not sold in the us, it is considered similar to devices that are based on its composition and syringe delivery mechanism. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2009-00108 |
| MDR Report Key | 1435846 |
| Report Source | 01,05 |
| Date Received | 2008-08-07 |
| Date of Report | 2009-07-16 |
| Date of Event | 2009-04-21 |
| Date Mfgr Received | 2009-07-16 |
| Date Added to Maude | 2009-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY DETREY |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ D-78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETREY CONDITIONER 36 |
| Product Code | EBC |
| Date Received | 2008-08-07 |
| Model Number | NA |
| Catalog Number | 60615208 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY |
| Manufacturer Address | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2008-08-07 |