MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-05-05 for PHILIPS LUMEA COMFORT SC1981/00 manufactured by Philips Medical Systems International Bv.
[44487909]
This is the first time this type of complaint has been received. It is not known if the consumer had a pre-existing condition that would have caused the diagnosis. The unit has been requested back from the consumer for investigation and analysis. Without an investigation of the actual unit, we are unable to confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10
[44487910]
Consumer claims that when using the device over her calf she pressed the button for a flash, but the flash did not come on instantly. She had time to pull the device and just at that time the flash occurred. She was looking directly into the light and saw white marks in her sight for a few hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009226815-2016-00003 |
| MDR Report Key | 5634002 |
| Report Source | CONSUMER |
| Date Received | 2016-05-05 |
| Date of Report | 2016-03-25 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-25 |
| Date Added to Maude | 2016-05-05 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NINA RUIZ |
| Manufacturer Street | 1600 SUMMER STREET |
| Manufacturer City | STAMFORD CT 06912 |
| Manufacturer Country | US |
| Manufacturer Postal | 06912 |
| Manufacturer Phone | 2033515949 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV |
| Manufacturer Street | BOXCHDIJK 525 |
| Manufacturer City | EINDHOVEN, 5621JG |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5621 JG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS LUMEA COMFORT |
| Generic Name | IPL GEX |
| Product Code | OHT |
| Date Received | 2016-05-05 |
| Model Number | SC1981/00 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV |
| Manufacturer Address | BOXCHDIJK 525 EINDHOVEN, 5621JG NL 5621 JG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-05 |