MAUDE Adverse Event Report: MO016 MO-MOBERLY INSTANT COLD PACKS, 2CT; PACK, HOT OR COLD, DISPOSABLE

Model Number 11440-900R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Pain (1994); Complaint, Ill-Defined (2331); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/1980

Event Type  Injury  

Manufacturer Narrative

At the time of this investigation, no samples or lot numbers were provided to cardinal health.Therefore; without a lot number we were not able to review the device history record and without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.As with all reports of alleged defects we will continue to educate operators and will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

Event Description

Based on information received the plaintiff alleges she was injured by suffering a serious and permanent wound to the back of her right calf causing a second degree burn injury which required medical treatment, diagnostic studies and other medical care.Plaintiff has and will continue to become liable for medical costs associated with her treatment, has suffered a loss of wages and earning capacity, suffered psychological and physical pain and suffering as a result as well as loss of enjoyment of life's pleasures.Plaintiff's injuries are permanent to the degree that she will no longer be able to maintain the same state of well being as before the incident complained of.

• Brand Name: INSTANT COLD PACKS, 2CT
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 8385867
• MDR Text Key: 137668073
• Report Number: 1423537-2019-00280
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380132056
• UDI-Public: 10885380132056
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 11440-900R
• Device Catalogue Number: 11440-900R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other