HYDROCOLLATOR 2202/2204 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-31 for HYDROCOLLATOR 2202/2204 * manufactured by Dynatronics Corp. Chattanooga Operations.

Event Text Entries

[2780391] After the discharge from the emg (electromyogram) lab, the patient's family called to report that patient had a red area on the abdomen where the hydrocollator pad had been. The family brought the patient to the er (emergency room) later that evening because of increased pain and blistering. The area was described as a 10 x 8 cm red area in the middle of the abdomen with mild blistering above the umbilicus. The treatment was bacitracin topical ointment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2679261
• MDR Report Key: 2679261
• Date Received: 2012-07-31
• Date of Report: 2012-07-31
• Date of Event: 2012-07-24
• Report Date: 2012-07-31
• Date Reported to FDA: 2012-07-31
• Date Added to Maude: 2012-08-02
• 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: 3
• 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: HYDROCOLLATOR
• Generic Name: MOIST THERAPY PACK CONDITIONER
• Product Code: IMA
• Date Received: 2012-07-31
• Model Number: 2202/2204
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 5 YR OLD
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DYNATRONICS CORP. CHATTANOOGA OPERATIONS
• Manufacturer Address: 6607 MOUNTAIN VIEW RD. COLLEGE DALE TN 37363 US 37363

Device Sequence Number: 2

• Brand Name: DYNAHEAT HOT PACK - STANDARD, 10X12 IN
• Generic Name: HOT PACK
• Product Code: IME
• Date Received: 2012-07-31
• Model Number: 1006
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DYNATRONICS CORP. CHATTANOOGA OPERATIONS
• Manufacturer Address: 6607 MOUNTAIN VIEW RD. COLLEGE DALE TN 37363 US 37363

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-31