PHORESOR II AUTO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-11 for PHORESOR II AUTO * manufactured by Rehabilicare.

Event Text Entries

[16036665] Add'l info rec'd from distributor 2/22/01: this letter is to inform you that rehabilicare is not the mfr of the iomed phoresor ii identified. However, they do distribute the device for the mfr iomed. Distributor has contacted iomed and have forwarded a copy of the report to the iomed.
Patient Sequence No: 1, Text Type: D, B5

[16402268] Iontophoresor used for hip bursitis. Pt reported feeling electrical stimulation during treatment, denied pain. Small blister noted on hip after treatment with some redness around the area. Parameters were 40 amps per min, 3. 5 intensity. Iomed iogel iontophoresis electrode used with 1. 5 cc dexamethasone. No follow up treatment needed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1020643
MDR Report Key	309409
Date Received	2000-12-11
Date of Report	2000-12-11
Date of Event	2000-10-31
Date Added to Maude	2000-12-26
Event Key	0
Report Source Code	Voluntary 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	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	PHORESOR II AUTO
Generic Name	IONTOPHORESOR
Product Code	KTB
Date Received	2000-12-11
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	299365
Manufacturer	REHABILICARE
Manufacturer Address	5802 BREKENRIDGE PKWY, STE 200 TAMPA FL 33610 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-12-11