MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-19 for COMFORT GEL 1010640 manufactured by Respironics.
[913343]
I have been experiencing acute contact dermatitis hives and extreme discomfort for the past 8 months from possible bispenol a or silicone leaching from bipap masks for sleep apnea. The company has instructed me to stop wearing the mask, but i have no other options for sleep apnea masks. I have been unable to find a lab that tests for silicone and bisphenol a concentrations in blood and urine. Please, may someone assist in helping to resolve this problem! Dose or amount: 6-8 hours a night. Frequency: daily use. Route: cutaneous. Dates of use: 2006 - 2008, 6-8 hours per day. Diagnosis or reason for use: sleep apnea. Event abated after use stopped or dose reduced? : no. Event reappeared after reintroduction? : yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008032 |
| MDR Report Key | 1128062 |
| Date Received | 2008-08-19 |
| Date of Report | 2008-08-19 |
| Date of Event | 2008-01-01 |
| Date Added to Maude | 2008-08-27 |
| 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 | 3 |
| 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 | COMFORT GEL |
| Generic Name | COMFORT GEL MASK |
| Product Code | NMC |
| Date Received | 2008-08-19 |
| Model Number | 1010640 |
| Lot Number | 071208 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1131477 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-19 |