MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR; HOT OR COLD DISPOSABLE PACK.

Model Number THERMACARE HEATWRAPS - NECK, WRIST & SHOULDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Partial thickness (Second Degree) Burn (2694); Skin Burning Sensation (4540)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Event Description

On (b)(6) 2021, bridges consumer healthcare received the following report from angelini (b)(4).The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from (b)(6) received on (b)(6) 2021 from a patient through diamed (de1373).This case report concerns a female patient with no relevant medical history, who applied waermeauflagen f¿r nacken, schulter und handgelenk (thermacare neck shoulder wrist 12 hour) lot number: unknown expiry date: unknown) topically administered for neck pain.Concomitant medications were not reported.In (b)(6) 2021, after thermacare (waermeauflagen f¿r nacken, schulter und handgelenk) initiation, the patient experienced burn blister, burning sensation and headache.After use of no more than 12 hours the patient suffered a burning sensation, headache and burn blisters.The patient reported that three days later the burning sensation was still present and that she still experienced pain.The report also included pictures of the burn marks taken on (b)(6) 2021, on (b)(6) 2021 and on (b)(6) 2021.Outcome: burn blister : unknown, burning sensation : not recovered/not resolved, headache : unknown.The reporter assessed this report as serious and didn't provide causal relationship to waermeauflagen f¿r nacken, schulter und handgelenk.The action taken in response to the events was unknown.For initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation: reportable near incident identified.

Event Description

On 28-may-2021, bridges consumer healthcare received the following report from angelini s.P.A.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 17-may-2021 from a patient through diamed ((b)(4)).This case report concerns a female patient with no relevant medical history, who applied waermeauflagen für nacken, schulter und handgelenk (thermacare neck shoulder wrist 12 hour) lot number: unknown expiry date: unknown) topically administered for neck pain.Concomitant medications were not reported.In (b)(6) 2021, after thermacare (waermeauflagen für nacken, schulter und handgelenk) initiation, the patient experienced burn blister, burning sensation and headache.After use of no more than 12 hours the patient suffered a burning sensation, headache and burn blisters.The patient reported that three days later the burning sensation was still present and that she still experienced pain.The report also included pictures of the burn marks taken on (b)(6) 2021.Outcome: burn blister: unknown, burning sensation: not recovered/not resolved, headache: unknown.The reporter assessed this report as serious and didn't provide causal relationship to waermeauflagen für nacken, schulter und handgelenk.The action taken in response to the events was unknown.For initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation: reportable near incident identified.

Manufacturer Narrative

On 28-may-2021, angelini s.P.A.Provided the following information to bridges consumer healthcare.The information was received by angelini s.P.A.On 17-may-2021.The report verbatim is as follows: reportable near incident identified.Investigation in progress.On 28-jun-2021, angelini s.P.A.Provided bridges consumer healthcare additional follow up information.The information was received by angelini s.P.A.On 15-jun-2021.The report verbatim is as follows: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 12hr product.There was limited device specific information provided.No batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) were performed: citi scope: date contacted: 05/17/2018 through 03/14/2021/ manufacturing site: pfizer albany/complaint class: external cause investigation/complaint sub class: adverse event safety request for investigation twd scope: date contacted: 03-15-2021 through 05-17-2021.Manufacturing site: angelini albany / complaint class: undesirable side effect / complaint sub class: adverse event safety request for investigation the citi and twd search returned a total (b)(4) complaints for the neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.The data shows an increase for november 2018 through february 2019.This increase is attributed to seasonality change.There is not a trend identified for the subclass of adverse event safety request for investigation for neck/shoulder/wrist (nsw) 12hr products.Refer to the 36-month attached trend chart adverse event safety request for investigation nsw 12hr 05-17-2018 to 05-17-2021.There is no further action required.Root cause investigation required: no capa required: no.Is root cause confirmed? no.Has the risk assessment been reviewed? no, risk analysis summary is not required as this complaint is not justified.Based on the information provided, the events burn blister, headache and burning sensation 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 neck shoulder wrist 12 hour does not mention that burn blister and headache could be adverse events of this medical device, whereas it mentions burning sensation 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 neck shoulder wrist 12 hour and events is considered as possible.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 12hr product.There was limited device specific information provided.No batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) were performed: there is not a trend identified for the subclass of adverse event safety request for investigation for neck/shoulder/wrist (nsw) 12hr products.There is no further action required.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11938873
• MDR Text Key: 262664140
• Report Number: 3007593958-2021-00019
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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 - NECK, WRIST & SHOULDER
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention