VITAMIN D LAMP VITAMIN D LAMP D/UV (CLEAR BULB)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-14 for VITAMIN D LAMP VITAMIN D LAMP D/UV (CLEAR BULB) manufactured by Sperti Kdb.

Event Text Entries

[5159090] Here is the message that i sent to (b)(4) on (b)(6) 2014: dear (b)(4): please see the attached photographs of the older bulb (which, i guess, looks fine). I've also attached photographs of the replacement bulb which you recently mailed to me. You questioned whether the bulb cracked during shipment. I don't see any white substance. But both bulbs do not work. I'm going to send another email with a video of the unit and its timer during operation. The video was reduced to about 120 pixels or so and 1 frame per second in order to fit within the email limitations. " (b)(4) wrote back: "there is nothing wrong with the ceramic or the installation of the bulb. This leads me to believe that the problem is electrical. We no longer have parts for these lamps, so repair is not an option. You can send the bulb back and we can offer a (b)(4) on the purchase of a new lamp because you are an owner of the older lamp. Your cost for a new lamp would be (b)(4) including shipping. " here is the copy of the (b)(4) complaint which i filed: "i sent an email to (b)(4) weeks ago but did not receive a response. Fortunately, within the past week, (b)(4) stepped in but only after my calling. (b)(4) promised to allow me to return the unit for repair. The other (b)(4), that is, the (b)(4), told me to purchase a new unit. A repair would not be possible. But here is a copy of the transcript from 1:22 am (b)(6) 2014. (b)(4): "send the unit in. " (an imperative) me: "what typically goes (kaput) in that unit? Like, is there a fuse that needs to be replaced? " (b)(4): "no sir, i mean usually if the timer is working, um, and it's you know... Usually one of two things. It's something with the timer. Or it would be the matter which bulb i use, the original or the replacement. I cannot locate any defects in either bulb. Moreover, (b)(4) claims that all bulbs are tested before shipment. Although microscopic cracks can develop, i do not see any "powder" which is what (b)(4) asked me to look for. In all, this is quite a poor quality product. It is unreliable units on the internet that have lasted for decades. I even find (b)(6) products from (b)(6). My unit says december 09 on the back and it has already failed after gentle and brief usage. The unit has been well-kept, well-maintained. I have followed all directions as outlined in the manual regarding the care and maintenance of this unit. It is unacceptable to pay so much for this device and yet receive so little in terms of reliability, usage. Issues: advertisement of a service (repair) that is not available, a failure to honor a contract or agreement (for the unit to be repaired); unauthorized changes to the contract or agreement (no longer allowing the repair of the unit); customer service failed to provide assistance (at first); the failure to respond to phone calls or written requests for assistance or support (at first); the inappropriate behavior by customer service personnel (offering a repair but subsequently not honoring to repair it); the company failed to honor a verbal commitment (to repair); a dispute regarding the warranty coverage and/or terms (poor quality); the product i purchased was defective (failed prematurely); the failure to honor a repair estimate or agreement (agreement to repair); an improper or inferior (customer) service (refusal to repair). Desired settlement: other (requires explanation).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038687
MDR Report Key4190260
Date Received2014-10-14
Date of Report2014-10-14
Date of Event2014-03-01
Date Added to Maude2014-10-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVITAMIN D LAMP
Generic NameVITAMIN D LAMP
Product CodeFTC
Date Received2014-10-14
Model NumberVITAMIN D LAMP D/UV (CLEAR BULB)
ID NumberDECEMBER 2009
OperatorOTHER
Device Sequence No1
Device Event Key0
ManufacturerSPERTI KDB


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-14

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