MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for HYGENIC H09105 manufactured by Coltene Whaledent Inc..
[124815749]
During a root canal, the non-latex dental dam split and came off over clamp patient was unaware of what happened. This product has been used many times before without an issue. All parts were retrieved and there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-2018-00013 |
| MDR Report Key | 7996461 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-10-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-23 |
| Catalog Number | H09105 |
| Lot Number | J072568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-10-23 |