MAUDE Adverse Event Report: MO016 MO-MOBERLY INSULATED COLD PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	20104
Health Effect - Clinical Codes	Peeling (1999); Skin Inflammation (2443)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review was completed on the reported lot v2k045.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One sample was received on 07/13/2018.After analyzing the sample, nothing wrong was found with it.Per the customers statement the product was placed in freezer prior to use.Product clearly states ¿do not freeze¿ as it might result in frostbite.A corrective action will not be initiated at this time as the customer failed to follow instructions for use.
Event or Problem Description
Based on the customers report she stated she had a used cold pack that she had received from a prior hospital visit and recently placed it in the freezer.Reportedly on (b)(6) 2018 she placed the frozen cold pack on her right knee and stated later noted a pink area on her skin that looked like a bad sun burn.The skin peeled.She then looked over the cold pack and noted it did state do not freeze and she admitted she had not read the cold pack thoroughly before use.She did not seek any medical treatment.

• Brand Name: INSULATED COLD PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7706336
• Report Number: 1423537-2018-00225
• Device Sequence Number: 1328842
• Product Code: IMD
• UDI-Device Identifier: 00630140039716
• UDI-Public: 00630140039716
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 20104
• Device Catalogue Number: 20104
• Device Lot Number: V2K045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR