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

Lot Number EA5724

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

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

On 12-jan-2022, (b)(4).Notified bridges consumer healthcare of the following case.(b)(4).Received the case on 31-dec-2021.The report per verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from (b)(6) received on 30-dec-2021 from a pharmacist through diamed ((b)(4)).This case report concerns a female patient (approximately (b)(6)), who applied thermacare neck shoulder wrist (batch number ea5724, expiry date unknown) for unknown indication.Concomitant medications and medical history were not reported.On an unknown date after thermacare neck shoulder wrist initiation, the patient experienced burn blister, redness.The patient suffered from redness in shape of a button and two burn blisters.Outcome: burn blister : unknown, redness : unknown.The action taken in response to the events for thermacare neck shoulder wrist was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the next report is 18-feb-2022.

Event Description

On 12-jan-2022, angelini s.P.A.Notified bridges consumer healthcare of the following case.Angelini s.P.A.Received the case on 31-dec-2021.The report per verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 30-dec-2021 from a pharmacist through diamed (de1755).This case report concerns a female patient (approximately 30 years of age), who applied thermacare neck shoulder wrist (batch number ea5724, expiry date unknown) for unknown indication.Concomitant medications and medical history were not reported.On an unknown date after thermacare neck shoulder wrist initiation, the patient experienced burn blister, redness.The patient suffered from redness in shape of a button and two burn blisters.Outcome: burn blister : unknown, redness : unknown.The action taken in response to the events for thermacare neck shoulder wrist was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the next report is 18-feb-2022.On 25-jan-2022, bridges consumer healthcare received additional information from angelini s.P.A.Angelini s.P.A.Received the follow up information on 12-jan-2022.The verbatim is as follows: follow-up received on 12-jan-2022 from qa department.Complaint number: (b)(4).Batch #: ea5724 product count: 2-count brand code/sku#: f00573300723w date of manufacture: 12-jun-2020 through 17-jun-2020 expiry date: 2023-may-31 quantity released: (b)(4) cartons batch ea5724 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.Per trn-(b)(6), consumer return samples and retain evaluations, effective 23- oct-2021, section 8.2: inspection of retain samples.The visual evaluation of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-000094632 retain sample inspection form was used to document the retain evaluation on 04-jan-2022.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 3.6.This result was below the upper control limit (ucl) of 76.2 complaints per trn-(b)(6) complaint trending guideline, effective 29-apr-2021.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c to 41.6 degrees c) per pal-(b)(4), thermacare nsw 12hr unprinted (printed laminate) specification, effective date: 03-dec-2019.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap temperature.Capa required: no.Root cause investigation required: no.Based on the information provided, the events burn blister and redness 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 could be an adverse event of this medical device, whereas it mentions redness 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 and incident is considered as possible.Batch ea5724 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap temperature.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• 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: 13320510
• MDR Text Key: 288850024
• Report Number: 3007593958-2021-00055
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Lot Number: EA5724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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 Age: 30 YR
• Patient Sex: Female