MEGA PULSE II A.C.P 1903029 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-20 for MEGA PULSE II A.C.P 1903029 NA manufactured by Acp Accelerated Care Plus.

Event Text Entries

[1641620] Used diathermy to decrease pain at coccyx area "4... T", have used this several times with no heat complaints from pt. Today pt complained of heat, stated "my butt is hot", when checked, skin was very hot to touch, redness seen at that time. Patient complains excessive heat on coccyx area during diathermy treatment. Twelve minutes into 20 minute treatment time, pt complains of his butt "burning hot", treatment stopped. Checked skin, without gloves , pt's skin was "hot" to touch, redness seen, diathermy used without pt having sheet, undergarments and duoderm patch on. Pt rechecked 30 minutes after, redness and heat still apparent. Re-checked again 1 1/2 hrs, slight redness seen. Re-checked again 3 hrs, no redness or irritation seen. Re-checked next day, no irritation or redness seen. Dose or amount: 20 min "4... T"; 20 min "2... T". Frequency: 2 or 3 times per week; 2 or 3 times per week. Route:. Diathermy - topical. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: decreased pain coccyx sore; decreased pain coccyx area. Event abated after use: yes. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5015646
• MDR Report Key: 1666387
• Date Received: 2010-04-20
• Date of Report: 2010-04-13
• Date of Event: 2010-04-08
• Date Added to Maude: 2010-05-11
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEGA PULSE II A.C.P
• Generic Name: DIATHERMY
• Product Code: IMJ
• Date Received: 2010-04-20
• Returned To Mfg: 2010-04-10
• Model Number: 1903029
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACP ACCELERATED CARE PLUS
• Manufacturer Address: 4850 JOULE ST STE A-1 RENO NV 89502 US 89502

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-04-20