MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-01-15 for PATIENT RELIEF WAX WB-GM manufactured by Glenroe Technologies.
[1311044]
It was reported that a patient developed an itchy rash on the hands and feet 3 - 4 hours after application of patient relief wax to bands that had been placed earlier. The wax was removed immediately. The rash reportedly spread over the entire body and developed into red patches resembling blisters. Two days later, the patient consulted a general practitioner and was prescribed piriton antihistamine. The patient also returned to the dental practice where it was noted that the entire oral mucosa was red and that the patient had red spots around the eyes. The patient reported that it took 3 - 4 days after removal of the bands before the reaction was 95% clear.
Patient Sequence No: 1, Text Type: D, B5
[8428143]
While it is unknown if the wax used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event is reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2009-00205 |
| MDR Report Key | 1580439 |
| Report Source | 01,08 |
| Date Received | 2010-01-15 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-11-18 |
| Date Mfgr Received | 2009-12-17 |
| Date Added to Maude | 2010-01-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | GLENROE TECHNOLOGIES |
| Manufacturer Street | 1912 44TH AVE, EAST |
| Manufacturer City | BRADENTON FL 34203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT RELIEF WAX |
| Product Code | EGD |
| Date Received | 2010-01-15 |
| Model Number | NA |
| Catalog Number | WB-GM |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLENROE TECHNOLOGIES |
| Manufacturer Address | BRADENTON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-15 |