ACUGLIDE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-04 for ACUGLIDE * manufactured by Helio Medical Supplies.

Event Text Entries

[4635651] To pain management unit for electroacupuncture treatment. Needles were placed and stimulation of needle occurred. At the end of the procedure all needles were removed intact except for one. This 26-gauge, 3cm needle broke off at the hub, and it was seen with fluoroscopy at the transverse process of l3 on the right. Physician attempted to retrieve it without success. Patient was referred to hospital for surgical removal under fluoroscopy which was successful. Manufacturer response for accupuncture needle, acuglide acupuncture needle mt1/ml1 25x30 mm (per site reporter). ======================rep made aware; have not heard back as of this report.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3975815
MDR Report Key	3975815
Date Received	2014-06-04
Date of Report	2014-06-04
Date of Event	2014-05-16
Report Date	2014-06-04
Date Reported to FDA	2014-06-04
Date Reported to Mfgr	2014-08-04
Date Added to Maude	2014-08-04
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	ACUGLIDE
Generic Name	NEEDLE, ACUPUNCTURE, SINGLE USE
Product Code	MQX
Date Received	2014-06-04
Model Number	*
Catalog Number	*
Lot Number	00926003
ID Number	*
Operator	PHYSICIAN
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	HELIO MEDICAL SUPPLIES
Manufacturer Address	2076 ZANKER RD, SAN JOSE CA 95131 US 95131

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-06-04