MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-21 for PT RELIEF WAX WB-HS manufactured by Glenroe Technologies.
[1106337]
It was reported that a pt experienced swelling of the lip within ten minutes of placing relief wax; the complainant indicated that medical treatment was sought, though did not specify the type of treatment.
Patient Sequence No: 1, Text Type: D, B5
[8351583]
While it is unk if the wax used in this case caused or contributed to the pt'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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2009-00084 |
| MDR Report Key | 1421195 |
| Report Source | 08 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-06-22 |
| Date Mfgr Received | 2009-06-22 |
| Date Added to Maude | 2009-07-29 |
| 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 | SUSQUEHANNA COMMERCE CTR W 221 W PHILA ST, STE 60 |
| 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 | PT RELIEF WAX |
| Product Code | EGD |
| Date Received | 2009-07-21 |
| Model Number | NA |
| Catalog Number | WB-HS |
| Lot Number | 150432 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| 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. Other | 2009-07-21 |