INTERFERENTIAL ENDOMED M 433 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-09 for INTERFERENTIAL ENDOMED M 433 * manufactured by Enraf-nonius B.v..

Event Text Entries

[16272805] Outpatient rehab patient sustained a burn by an electrode during physical therapy. It was unknown at the time of occurrence. Reported at the follow-up treatment visit. Manager feels that it was not a machine malfunction, that the electrodes lost contact with the skin due to movement and/or the treatment area. Both machines checked by biomed department after occurrence. Injured area: right buttock, approximately 1 cm width, very narrow and 1-2 mm depth.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 555745
• MDR Report Key: 555745
• Date Received: 2004-09-09
• Date of Report: 2004-09-09
• Date of Event: 2004-05-11
• Report Date: 2004-09-09
• Date Reported to FDA: 2004-09-09
• Date Added to Maude: 2004-11-22
• 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 Sequence Number: 1

• Brand Name: INTERFERENTIAL
• Generic Name: PERIPHERAL NERVE STIMULATOR
• Product Code: KOI
• Date Received: 2004-09-09
• Model Number: ENDOMED M 433
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 545394
• Manufacturer: ENRAF-NONIUS B.V.
• Manufacturer Address: RONTGENWEG 1 P.O. BOX 810 2600 AV DELFT US

Device Sequence Number: 2

• Brand Name: INTERFERENTIAL
• Generic Name: PERIPHERAL NERVE STIMULATOR
• Product Code: KOI
• Date Received: 2004-09-09
• Model Number: ENDOMED 433
• Catalog Number: *
• Lot Number: MODEL/PART 1433.902
• ID Number: *
• Device Availability: N
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 545395
• Manufacturer: ENRAF-NONIUS
• Manufacturer Address: RONTGENWEG 1 P.O. BOX 810 2600 AV DELFT US

Device Sequence Number: 3

• Brand Name: GENTLE STIM R PLUS
• Generic Name: REUSABLE SELF-ADHERING TENS/FES/NMS ELECTRODES WITH PIGTAIL
• Product Code: GZJ
• Date Received: 2004-09-09
• Model Number: PART 42093
• Catalog Number: *
• Lot Number: 25651203184
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 545396
• Manufacturer: NATIONAL MEDICAL ALLIANCE
• Manufacturer Address: 8100 SOUTH AKRON 320 ANGLEWOOD CO 80112 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-09
2	0		2004-09-09
3	0		2004-09-09