MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. INSTANT WARM COMPRESS; PACK, HOT OR COLD, DISPOSABLE

Catalog Number CWP901

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Discomfort (2330)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

Warm compress used on a patient that was experiencing discomfort with a chemo treatment.Once used the compress was too warm and caused discomfort and redness.

• Brand Name: INSTANT WARM COMPRESS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 8385856
• MDR Text Key: 137704547
• Report Number: 8385856
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CWP901
• Device Lot Number: 24918/2//
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1