MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-12 for HENRY SCHEIN SUPER CONCENTRATED GENERAL PURPOSE 1721362FG manufactured by Dentsply Professional.
[72622339]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[72622340]
While using a schein sc ultrasonic gp 16oz cleaner, a hygienist experienced an allergic reaction. The hygienist broke out in a rash and went to go see her doctor for treatment. The patient was prescribed antibiotics and the symptoms abated approximately one week later.
Patient Sequence No: 1, Text Type: D, B5
[101391549]
During dhr review audit, it was noticed that a calculation error was made when calculating % btc. The reported result was 7. 20%. The correct calculation produces 7. 99%. The specification for the product is 6. 13-7. 49%. No other errors were found during the audit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2017-00034 |
| MDR Report Key | 6487280 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-12 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-04-12 |
| 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 | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457551 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARK 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 | HENRY SCHEIN SUPER CONCENTRATED GENERAL PURPOSE |
| Generic Name | CLEANER, ULTRASONIC, MEDICAL INSTRUMENT |
| Product Code | FLG |
| Date Received | 2017-04-12 |
| Returned To Mfg | 2017-03-31 |
| Model Number | NA |
| Catalog Number | 1721362FG |
| Lot Number | 160915 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROFESSIONAL |
| Manufacturer Address | 1301 SMILE WAY YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-12 |