MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-10-11 for 5 X 5 GREEN THIN READY CUT DAM H02141 manufactured by Coltene/whaledent Inc..
[20334530]
Anaphylaxis reaction. Patient was taken to the hospital by an ambulance and admitted by a doctor, however she was discharged from the hospital next day.
Patient Sequence No: 1, Text Type: D, B5
[20488253]
The investigation continues as this report is being written.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2416455-2013-00001 |
| MDR Report Key | 3415716 |
| Report Source | 08 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-10-11 |
| Date of Event | 2013-09-12 |
| Date Facility Aware | 2013-09-12 |
| Report Date | 2013-10-10 |
| Date Reported to Mfgr | 2013-09-12 |
| Date Mfgr Received | 2013-09-12 |
| Date Added to Maude | 2013-10-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GLENN PERSILLO |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168837 |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 X 5 GREEN THIN READY CUT DAM |
| Generic Name | DENTAL DAM |
| Product Code | EIE |
| Date Received | 2013-10-11 |
| Model Number | H02141 |
| Catalog Number | H02141 |
| Lot Number | 27901 |
| Device Expiration Date | 2016-04-30 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2013-10-11 |