MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-26 for MEDLITE C6 659-0020 manufactured by Hoya Conbio.
[19255177]
According to the allegedly injured party, in 2006, a laser technician practitioner was performing a procedure using a medlite c6 laser at 6 j/cm2, 1064 nm, 10hz with a 4 mm spot size while compressing the skin with a glass window to force the blood away from the treatment site to minimize the formation of purpura. She reports that during the procedure, she noticed bright spots that caused her to blink. After the procedure, she noticed that there continued to be a "black" spot or shadow in her central vision similar to what happens after you look directly into a light bulb or the sun and then look away. She further reports that 3 days later, she went to see an ophthalmologist who examined her and found bleeing and referred her to a retinal specialist. We have not yet received her formal medical records. Sixteen days later, ms. Pham sent an email to an independent contractor working with hoya conbio, informing her of the adverse event. The independent contractor reviewed the email for the first time and reported the alleged injury to hoya for the first time 5 days later.
Patient Sequence No: 1, Text Type: D, B5
[19436086]
Device not evaluated as there is no defect or problem with the device. The event may be related to a lack of eyewear or the use of incorrect eyewear. The eyewear provided with the c6 laser system is to protect for use with the 1064 and 532 nm wavelengths. This eyewear has a slight amber tint. The reporter requested that a hoya representative send her a clear set of eyewear without the amber tint. Hoya sent clear eyewear to her, but sent eyewear rated only for 2940 nm. Upon receipt of the eyewear, she did not check the rating on the eyewear prior to using them. She used them for several months prior to 11/06. She claims to have been wearing this eyewear in 2006 when she allegedly received a back reflection off of the surface of the compression window she was using. The 2940 nm eyewear was removed from the treatment room immediately after the event and replacement eyewear with the correct protection was sent to institute on 12/20/06.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918486-2006-00002 |
| MDR Report Key | 800993 |
| Report Source | 07 |
| Date Received | 2006-12-26 |
| Date of Report | 2006-12-26 |
| Date of Event | 2006-11-03 |
| Date Mfgr Received | 2006-11-27 |
| Date Added to Maude | 2007-01-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM GREEN |
| Manufacturer Street | 47733 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104454528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLITE C6 |
| Generic Name | LASER, Q-SWITCHED ND: YAG |
| Product Code | LXS |
| Date Received | 2006-12-26 |
| Model Number | MEDLITE C6 |
| Catalog Number | 659-0020 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 788533 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | 47733 FREMONT BLVD. FREMONT CA 94538 US |
| Baseline Brand Name | MEDLITE C6 |
| Baseline Generic Name | ND: YAG Q-SWITCHED PULSED LASER SYSTEM |
| Baseline Model No | MEDLITE C6 |
| Baseline Catalog No | 659-0002 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-26 |