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

Model Number	11440-900R
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Complaint, Ill-Defined (2331); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 8385867
• Report Number: 1423537-2019-00280
• Device Sequence Number: 14013699
• Product Code: IMD
• UDI-Device Identifier: 10885380132056
• UDI-Public: 10885380132056
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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