MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,LRG,6X9"

Catalog Number	MDS139009
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by rn, nurse manager-apheresis, ucsd medical center, with additional information related to this incident.The reporter states, on (b)(6) 2020 a (b)(6) male came to the facility complaining of back pain.Reporter states, "the warm pack had no damage prior to activation.I activated it myself.Warm pack was placed on patients back per patient's request between the shirt and skin." reporter states the hot pack was removed after ten to fifteen minutes.Reporter states, she did not check the back at that time.The reaction was discovered four hours later after the stem cell collection.Reportedly the patient came back to the facility after discharge and followed up with the nurse practitioner (np) who discovered a superficial burn on the right scapula the size of a quarter and a rash across the patient's back, patient was given care instructions by the np and sent home.The reporter states, the patient returned the following day to the emergency department for back pain at which time the emergency room physician diagnosed the patient with shingles (herpes zoster).It is unknown how the patient received a superficial burn to the right scapula.The reporter at no time advised that they applied a hot pack to the patient's right shoulder.Due to the nature of the reported incident and out of an abundance of caution, this medwatch is being filed.The sample has been discarded and is not available for return.No further information is available at this time.If additional relevant information becomes available, a supplemental med watch will be filed.
Event or Problem Description
It was reported a hot pack burned a patient's right scapula.

• Common Device Name: PACK,HOT,INSTANT,LRG,6X9"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10785862
• Report Number: 1417592-2020-00120
• Device Sequence Number: 14372754
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MDS139009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/04/2020
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 125