MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-26 for RUBBER ORTHODONTIC BAND manufactured by Unknown.
[22180856]
Rptr is allergic to latex. She discovered her allergy via the use of rubber bands for orthodontics, a latex knee brace and the use of latex gloves. The rubber band resulted in mouth and face swelling and the knee brace and gloves resulted in a severe rash. Rptr is concerned about her allergy because she works in medical research and because of the unavailability of an alternative to latex condoms for protection against hiv and stds. Rptr was not previously allergic to latex until after prolonged orthodontic work. The rubber bands on her braces when she was 14 caused the allergic reaction. (also see 1003826 and 1003827. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003825 |
| MDR Report Key | 17185 |
| Date Received | 1994-10-26 |
| Date of Report | 1994-09-28 |
| Date Added to Maude | 1994-10-27 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUBBER ORTHODONTIC BAND |
| Generic Name | RUBBER BAND |
| Product Code | ECI |
| Date Received | 1994-10-26 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17118 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-10-26 |