MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for HYGENIC H11627 manufactured by Coltene Whaledent Inc..
[118246696]
Dental dam tore in patients mouth after getting wet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-2018-08237 |
| MDR Report Key | 7808692 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-08-23 |
| 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 | TRICIA CREGGER |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer G1 | COLTENE WHALEDENT INC. |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYGENIC |
| Generic Name | DENTAL DAM |
| Product Code | EIE |
| Date Received | 2018-08-23 |
| Catalog Number | H11627 |
| Lot Number | 160J7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE WHALEDENT INC. |
| Manufacturer Address | 235 ASCOT PARKWAY CUYAHOGA FALLS OH 44223 US 44223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-23 |