MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-13 for COMFORTGEL BLUE FULL 1081821 manufactured by Respironics Inc.
[179259128]
The manufacturer became aware that a user alleges, according to his dermatologist, usage of a mask caused him to develop skin cancer on his head. The exact date of the event is unknown. No further information is available at this time. The manufacturer's investigation is ongoing. Upon completion of the manufacturer's investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[184069785]
The manufacturer made several attempts to have the device returned for evaluation. To date, no product has been returned; therefore, no evaluation has been completed. If the device is returned following the submission of this report, a supplemental follow up report will be submitted with investigative findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2020-00369 |
| MDR Report Key | 9706299 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3349303 |
| Manufacturer G1 | RESPIRONICS INC |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORTGEL BLUE FULL |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-02-13 |
| Model Number | 1081821 |
| Catalog Number | 1081821 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |