TECHNO AID GARMENT TECHNO-AID LEADLESS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-30 for TECHNO AID GARMENT TECHNO-AID LEADLESS manufactured by Techno-aid.

Event Text Entries

[3113965] To whom it may concern: (b)(6) university purchased me a set of "leadless" leads when i functioned as an electrophysiology fellow at the institute. The lead brand is techno-aid garment with shirt serial number (b)(4) and skirt serial number (b)(4). I wore this lead for approximately 1 year and then it was checked for radiation leaks on (b)(6) by an individual at (b)(6) with the initials (b)(6). The lead checked out fine for "no leaks" and has a sticker verifying this. Upon beginning a new job at the (b)(6) center i asked to have my lead checked again for radiation leaks. There are gapping holes in radiation coverage throughout the garment and it is the "worse that has ever been seen" in over 15 years per the radiation supervisor at (b)(6) hospital. As a result, i have a sustained a large and unknown radiation dose given that i typically used radiation five days per week. In an effort to contact (b)(6) i discovered that multiple individuals at (b)(6) had the same problem that lead was removed from circulation. No one contacted me via my still active (b)(6) email account (which is listed in the (b)(6) address book) to inform me that my lead may be faulty. My peer fellow, dr. (b)(6) also received a large radiation dose for the same reason until his new lab in (b)(6) discovered the large holes in his coverage. He was also never contacted or notified in anyway. It is unclear how many others have this lead and do not know what they have an issue. I have not received any therapies but rather received an unk and likely very large radiation dose due to poor quality lead from techno-aide and poor supervision from the (b)(6) radiation safety department. Dates of use: (b)(6) 2010 - (b)(6) 2012. Reason for use: lead for electrophysiology procedures performed with xrt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5026768
MDR Report Key2732382
Date Received2012-08-30
Date of Report2012-08-30
Date of Event2010-07-08
Date Added to Maude2012-09-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECHNO AID GARMENT
Generic NameLEAD APRON
Product CodeEAJ
Date Received2012-08-30
Model NumberTECHNO-AID LEADLESS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerTECHNO-AID
Manufacturer AddressNASHVILLE TN US

Device Sequence Number: 2

Brand NameTECHNO-AID GARMENT
Generic NameSKIRT
Product CodeEAJ
Date Received2012-08-30
Model NumberTECHNO-AID LEADLESS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerTECHNO-AID
Manufacturer AddressNASHVILLE TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2012-08-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.