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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for the product "product severely burnt her stomach when she peeled them back.".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2021, a spontaneous case from the (b)(6) was received via a (b)(6) and (b)(6) regarding a female consumer who used thermacare lowerback and hip 8hr s/m 2ct heat wrap.Medical history and use of concomitant products were not provided.On an unspecified date the consumer used the thermacare lowerback and hip 8hr s/m 2ct heat wrap (lot and expiration date were not provided) for an unspecified indication.The consumer's mother reported that the product severely burnt her stomach when she peeled them back.The consumer had to go to her gp (general practitioner) and have treatment for her burns.The heat pads took a number of layers of her skin off.Further information is not expected as contact information for the reporter was not provided.

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for the product "product severely burnt her stomach when she peeled them back.".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.On 11-jun-2021, additional information was provided to bridges consumer healthcare from angelini s.P.A.The verbatim of the follow-up information is as follows: follow-up on 10-jun-2021 from qa albany dept.((b)(4)).Investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Limited device specific information provided, and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search performed: citi scope: date contacted: 23-apr-2018 through 14-mar-2021/manufacturing site: pfizer albany/complaint class: external cause investigation/complaint sub class: adverse event safety request for investigation.Twd scope: date contacted: 15-mar-2021 through 23-apr-2021/ manufacturing site: angelini albany /complaint class: undesirable side effect / adverse event safety request for investigation.The citi customizable and twd search returned a total of 538 complaints for lower back/hip (lbh) products during this period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The data shows a seasonality increase in dec-2018.The data shows a gradual increase starting in mar-2019 and apr-2019, with a spike in may-2019.Forty-nine of the 77 complaints received in apr-2019 were related to too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified.Ninety-eight of the 169 complaints in may-2019 were related to too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified.Complaints related too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified have a severity ranking of s1 per (b)(4) hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 01-sep-2020.Mar-2019 through may-2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473, and w37940 from apr-2019.According to (b)(4), hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 01-sep-2020, section 10.1.Market actions (recall), in apr-2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 (germany/switzerland), s23902 (uk/ireland), and w37940 (germany/switzerland).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation ((b)(4), legacy qts, closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming product.Based on this customizable citi and twd search, a trend does not exist for the subclass adverse event safety request for investigation for lbh 8hr products.No further action is required.Capa required: no.Root cause investigation required: no.Based on the information provided, the events exfoliation and medical device site burn as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The pi of thermacare lower back and hip 8hr s/m 2ct does not mention that exfoliation could be an adverse event of this medical device, whereas it mentions medical device site burn as adverse event.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip 8hr s/m 2ct and events is considered as possible.Investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Limited device specific information provided, and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search performed: based on this customizable citi and twd search, a trend does not exist for the subclass adverse event safety request for investigation for lbh 8hr products.No further action is required.

Event Description

On 23-apr-2021, a spontaneous case from great britain was received via a loyd's pharmacy clinical care and mckesson regarding a female consumer who used thermacare lowerback and hip 8hr s/m 2ct heat wrap.Medical history and use of concomitant products were not provided.On an unspecified date the consumer used the thermacare lowerback and hip 8hr s/m 2ct heat wrap (lot and expiration date were not provided) for an unspecified indication.The consumer's mother reported that the product severely burnt her stomach when she peeled them back.The consumer had to go to her gp (general practitioner) and have treatment for her burns.The heat pads took a number of layers of her skin off.Follow up attempts have not been succesful in obtaining additional information.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M 2CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11863352
• MDR Text Key: 252399572
• Report Number: 3007593958-2021-00015
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: THERMACARE HEATWRAPS - LOWER BACK & HIP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention