PHORESOR II PM 700 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-03 for PHORESOR II PM 700 N/A manufactured by Motion Control, Inc..

Event Text Entries

[3364] Patient received a treatmrnt of iontophores on 5/25/93 to her left arm. On 5/27/93 she returned to the rehab clinic with a wound to the ventral aspect of her arm where she received the ionotophoresis. Teh wound was approximately one (1) inch in diameter and had a well formed scab over it. It was surrounded by some red area - no pus or drainage noted. Patient stated at the time she was receiving the iontophoresis that it felt the same as always and she did not note anything different. Patient continued and extension for both wrists ina passive mode with her resisting eccentrically. She continues to be much improved and wound area on the ventralaspect on her left arm is healingdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device returned to manufacturer/dealer/distributor, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5628
• MDR Report Key: 5628
• Date Received: 1993-07-03
• Date of Event: 1993-05-25
• Date Facility Aware: 1993-05-27
• Date Reported to Mfgr: 1993-06-29
• Date Added to Maude: 1993-07-19
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• 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: PHORESOR II
• Generic Name: IONTOPHORESIS UNIT
• Product Code: KTB
• Date Received: 1993-07-03
• Model Number: PM 700
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5327
• Manufacturer: MOTION CONTROL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-03