MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR S/M 2CT; 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 Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The original manufacturer report from the previous pfizer submission (1066015-2021-00028) included the following: on (b)(6) 2021, the product quality complaint group provided the following investigation results that yielded no product quality issues.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters after using thermacare".The cause of the consumer stating the wrap caused "burn blisters after using thermacare" 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 to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (25feb2021): new information received from pfizer product quality group includes: investigation results.
Event or Problem Description
The following case was received via (b)(6).On (b)(6) 2021 via pfizer.This is a follow up report for the previously pfizer submitted 30 day report case ((b)(4) ) due to the product being acquired by bridges consumer healthcare.The original report from the previous pfizer submission included the following: this is a spontaneous report from a contactable consumer (parent of patient) via angelini pharma regaring a patient from (b)(6).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cw8013, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient got burn blisters after using a patch.The action taken in response to the event(s) for thermacare heatwrap and the clinical outcome of the event were unknown.On (b)(6) 2021, the product quality complaint group provided the following investigation results that yielded no product quality issues.The follow up report that angelini s.P.A.Provided consisted of the following: on 30-mar-2021, additional information received by angelini pharma through diamed (de1082).The patient was a (b)(6) year-old female patient who weighed 93 kg and had a height of 168 cm.The patient took thermacare heat wraps (lot cw8013 expiry date nov-2022) for back pain once on (b)(6) 2021 for 2 hours.Medical history included that the patient had a medium light skin tone, no underlying skin diseases, no sensitive skin, she wasn't pregnant, and reported a previous use of thermacare heat wraps on (b)(6) 2020, that was well tolerated.On (b)(6) 2021, the patient experienced a sudden increase in temperature after 2 hours of using a thermacare heat wrap.The patient reported burn marks and blisters on the skin.The event was reported as not recovered.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11746091
• Report Number: 3007593958-2021-00008
• Device Sequence Number: 4319050
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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 Expiration Date: 11/30/2022
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: CW8013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: 24 YR
• Patient Weight: 93