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

Model Number THERMACARE HEATWRAPS - MUSCLE & JOINT

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 288850077
• Report Number: 3007593958-2021-00049
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: THERMACARE HEATWRAPS - MUSCLE & JOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/03/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female