MAUDE Adverse Event Report: ANGELINI THERMACARE MUSCLE/JOINT 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number	THERMACARE HEATWRAPS - MUSCLE & JOINT
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable near incident identified.Investigation in progress.
Event or Problem Description
On 03-dec-2021, a spontaneous report from the united states was received via email regarding a female (age not reported) who attempted to use thermacare heatwraps muscle pain therapy.Medical history and concomitant products were not provided.On an unspecified date, the consumer opened a package of thermacare heatwraps muscle pain therapy (lot number ga0022: expiration date not provided).On an unspecified date, after opening a package of thermacare heatwraps muscle pain therapy, the consumer noted that the one of the heat wraps came apart.It was clarified that the heating element opened up.No additional information was provided.
Event or Problem Description
On 03-dec-2021, a spontaneous report from the united states was received via email regarding a female (age not reported) who attempted to use thermacare heatwraps muscle pain therapy.Medical history and concomitant products were not provided.On an unspecified date, the consumer opened a package of thermacare heatwraps muscle pain therapy (lot number ga0022: expiration date not provided).On an unspecified date, after opening a package of thermacare heatwraps muscle pain therapy, the consumer noted that the one of the heat wraps came apart.It was clarified that the heating element opened up.No additional information was provided.
Additional Manufacturer Narrative
Reportable near incident identified.Investigation in progress.On 06-jan-2022 bridges consumer healthcare received additional information from angelini.On 03-jan-2022, angelini received additional information regarding the investigation.The verbatim information is as follows: the site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, retain sample evaluation, and production controls met the product release criteria.Consumer reports "one of the heat wraps came apart.The heating element opened up".The cause of the consumer stating she "one of the heat wraps came apart.The heating element opened up" is inconclusive since review of records does not provide evidence to support defective product.The wrap is not available for evaluation, the root cause of the "heating element opened up" cannot be determined.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR 3CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 13121847
• Report Number: 3007593958-2021-00049
• Device Sequence Number: 4620324
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: THERMACARE HEATWRAPS - MUSCLE & JOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female