MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Peeling (1999); Blister (4537)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause can not be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " blisters and other skin irritations".The cause of the consumer stating she received burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a blister and skin irritation; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
This spontaneous report from the united states was received on 29-may-2021 via email from consumer regarding a (b)(6) year-old female.The consumer applied the device on (b)(6) 2021 at around 1130 to her back and belly and reporting that the device felt warm/nice and she did not feel any burning or itching.The consumer began feeling uncomfortable with device around 1800 after work.Upon removal of the device, the consumer found blisters and skin peeling at application site on back.She also reports pain at application site where the site touched her clothing.She reports a total wear time of about seven hours.The outcomes of events were unknown at the time of report.Follow up attempts were made to contact consumer but were unsuccessful.

• Brand Name: THERMACARE LOWER BACK & HIP
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12052060
• Report Number: 3007593958-2021-00021
• Device Sequence Number: 4411743
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/23/2021
• 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: 40 YR