MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-11 for HYGONIC FLEXDAM NON LATEX DENTAL DAM (PURPLE) DO 9945 LOW ELASTIC MODULUS manufactured by Coltene/whaledent, Inc.
[18582497]
Per allergist (as allergic reaction precaution) prednisone 20mg 2009 hs and in the next day. Root canal therapy at about 4 days prior at 9:30am and 5 days after. Slight rash and burning on face immediately when dam placed and contacted skin. Questioned endodontist re: material of dam, assured "non-latex" some redness and itching and burning of face when left office. By 1:30 pm full redness in area where dam had been placed, burning and itching on face. Raspy voice, throat swelling, difficulty breathing, asthma flare-up. Notified allergist: prescribed prednisone, benadryl, topical cortisone ointment and increased inhalers use. Reaction started to decrease within 2 hours. Completely cleared by at about 5 days later. No residual adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012787 |
| MDR Report Key | 1481564 |
| Date Received | 2009-09-11 |
| Date of Report | 2009-09-10 |
| Date of Event | 2009-09-03 |
| Date Added to Maude | 2009-09-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYGONIC FLEXDAM NON LATEX DENTAL DAM (PURPLE) |
| Generic Name | DENTAL DAM |
| Product Code | EIE |
| Date Received | 2009-09-11 |
| Model Number | DO 9945 |
| Catalog Number | LOW ELASTIC MODULUS |
| ID Number | 30 PIECES 6X6IN 152X152MM |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE/WHALEDENT, INC |
| Manufacturer Address | 235 ASCOT PARKWAY CUYASHOGA FALLS OH 44223 US 44223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-11 |