MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for DRY TIPS 291543 291453 manufactured by Young Microbrush Llc.
[55004075]
It was confirmed that the product did not contain any of the items that the patient was reported to be allergic to. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[55004078]
The dentist reports an allergic reaction of a patient after "dry tips small" have been put in the patients mouth. (ref no. : 291543; batch: 275981). The patient got a local anesthesia with ultracain ds forte. Approximately 45min later in the procedure the dry tip has been put into the patients mouth and immediately after that, the left half of the face began to swell and got reddened (erythema). The reaction was visible on the left side of the face up to the patients eye. The dentist took out the dry tip immediately and cooled the face, which reduced the swelling a little. In addition an ambulance has been called. It was known that the patient has a latex and a wood resin allergy. Therefore the patient was treated latex-free.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002134751-2016-00001 |
| MDR Report Key | 5957221 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-08-15 |
| Date Mfgr Received | 2016-08-15 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2016-09-16 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH MOORE |
| Manufacturer Street | 1376 CHEYENNE AVE |
| Manufacturer City | GRAFTON WI 53024 |
| Manufacturer Country | US |
| Manufacturer Postal | 53024 |
| Manufacturer Phone | 2623754011 |
| Manufacturer G1 | YOUNG MICROBRUSH LLC |
| Manufacturer Street | 1376 CHEYENNE AVE |
| Manufacturer City | GRAFTON WI 53024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRY TIPS |
| Generic Name | SALIVA ABSORBENT |
| Product Code | KHR |
| Date Received | 2016-09-16 |
| Model Number | 291543 |
| Catalog Number | 291453 |
| Lot Number | 27598-1 |
| Device Expiration Date | 2019-04-25 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG MICROBRUSH LLC |
| Manufacturer Address | 1376 CHEYENNE AVE GRAFTON WI 53024 US 53024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |