HYDROCULATOR 552 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-29 for HYDROCULATOR 552 * manufactured by Chattanooga Pharmacal Co.

Event Text Entries

[337568] Hot moist pack applies on left knee by rna. Area inspected after 8 minutes and noted to be red and skin came off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 532560
• MDR Report Key: 532560
• Date Received: 2004-06-29
• Date of Report: 2004-06-17
• Date of Event: 2004-06-15
• Date Facility Aware: 2004-06-15
• Report Date: 2004-06-18
• Date Reported to FDA: 2004-06-25
• Date Added to Maude: 2004-07-06
• 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: PHYSICAL THERAPIST
• 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 Details

• Brand Name: HYDROCULATOR
• Generic Name: *
• Product Code: IMA
• Date Received: 2004-06-29
• Model Number: 552
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: 6 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 521834
• Manufacturer: CHATTANOOGA PHARMACAL CO
• Manufacturer Address: * CHATTANOOGA TN 37405 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-06-29