MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-12 for HYGENIC NON-LATEX FLEXI-DAM H09945 manufactured by Coltene/whaledent Inc..
[5167265]
Patient left the office and then called the office 20 minutes later to report the patient had hives over his body and would start taking benadryl for the reaction. Phone messages were left for the patient at 10:30am and also at 1:00pm. Patient returned provides call to indicate "the itchy sensation started when the purple thing was placed in my mouth". Confirmed with the patient that non-latex items were utilized for the patient and the patient was the first and only patient in the #10 operatory for the day. The patient indicated there was no further increase of symptoms once the antibiotic material was introduced into the canals. Patient was feeling better with the dose of benadryl.
Patient Sequence No: 1, Text Type: D, B5
[12870715]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2416455-2015-00001 |
| MDR Report Key | 4423292 |
| Report Source | 06 |
| Date Received | 2015-01-12 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-11-06 |
| Date Facility Aware | 2014-11-06 |
| Report Date | 2015-01-07 |
| Date Reported to Mfgr | 2014-12-09 |
| Date Mfgr Received | 2014-12-09 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-01-16 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | GLENN PERSELLO |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYGENIC NON-LATEX FLEXI-DAM |
| Generic Name | DENTAL DAM |
| Product Code | EIE |
| Date Received | 2015-01-12 |
| Model Number | NA |
| Catalog Number | H09945 |
| Lot Number | 140G |
| ID Number | NA |
| Device Expiration Date | 2018-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE/WHALEDENT INC. |
| Manufacturer Address | CUYAHOGA FALLS OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-12 |