MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number EF0007

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

Patient Problems Scar Tissue (2060); Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Event Description

This spontaneous report was received by (b)(6) on (b)(6) 2022 and was provided to (b)(6) healthcare on (b)(6) 2022.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on (b)(6) 2022 from a consumer/other non health professional through diamed (de2095).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number ef0007, expiration date unknown) for menstrual pain, on unknown date.Concomitant medication was not reported.Medical history included menstrual pain and a tattoo.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The patient used thermacare heat wraps due to menstrual pain.She had a tattoo on her belly (older) and it burned there.Outcome: burn : unknown.The action taken with thermacare heat wraps in response to the event was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.Additional information was received from angelini s.P.A.On by bridges consumer healthcare on 29-jul-2022.Angelini s.P.A.Received the information on 18-jul-2022.The verbatim is as follows: product count: 2 count.Brand code/sku#: f00573302020w.Date of manufacture: 22-aug-2020 to 26-aug-2020.Expiry date: 07/2023.Quantity released: 81,216 cartons.Batch ef0007 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Per trn-000096410, consumer return samples and retain evaluations, effective 23-oct-2021, section 8.2: inspection of retain sample and retain evaluation was performed.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-000094632 retain sample inspection form documented the retain evaluation performed on 15-apr-2021 for a previous unrelated complaint.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 12.3.This result was below the upper control limit (ucl) of 76.2 complaints per (b)(4), complaint trending guideline, approved 29-apr-2021, version 6.0.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 attribute and variable 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 (b)(4), therapeutic heat wrap/lower abdomen/thermacare menstrual ii, effective date: 03-dec-2019.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.Based on the information provided, the event burn as described in this case is 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 menstrual mentions that burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse eventmedical device is plausible.Based on the information provided the causal relationship between thermacare menstrual and event is considered as possible.Batch ef0007 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attribute and variable 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 (b)(4), therapeutic heat wrap/lower abdomen/thermacare menstrual ii, effective date: 03-dec-2019.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.

Event Description

This spontaneous report was received by angelini s.P.A.On 07-jul-2022 and was provided to bridges consumer healthcare on 15-jul-2022.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 07-jul-2022 from a consumer/other non health professional through diamed (de2095).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number ef0007, expiration date unknown) for menstrual pain, on unknown date.Concomitant medication was not reported.Medical history included menstrual pain and a tattoo.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The patient used thermacare heat wraps due to menstrual pain.She had a tattoo on her belly (older) and it burned there.Outcome: burn : unknown.The action taken with thermacare heat wraps in response to the event was unknown.Follow-up received on 17-aug-2022 from consumer through diamed.Information about patient's age was added: 25 years clarification about the event was provided: on the left side of the lower abdomen above the hip bone, the patient has a tattoo of about 5x10 cm (motif: heartbeat).As the patient was unsure whether the patch may be applied directly on the tattoo, she applied the patch on the right side of her lower abdomen next to the tattoo.When lying on the couch, the patch slipped in a way that the right side of the tattoo was partially covered by the patch (approx.1x2 cm).After about an hour, the patch got so hot that the patient immediately took it off.The patient experienced a burn blister on the part of her skin where the patch came into contact with the tattoo.At the time of this report, the patient has recovered from the burn blister.According to the patient, the coloration of her tattoo on the area of her skin that came into contact with the patch had faded and the skin looked scar-like.The event burn was changed in burn blister, and the events discoloration skin and medical device site scar were added.Follow-up was received on 17-aug-2022.Based on the new information provided, the events burn blister, discoloration skin and medical device site scar 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 menstrual does not mention that burn blister, discoloration skin and medical device site scar could be adverse events of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare menstrual and events is considered as possible.

Event Description

This spontaneous report was received by angelini s.P.A.On 07-jul-2022 and was provided to bridges consumer healthcare on 15-jul-2022.This serious spontaneous case, manufacturer control number 2022-028174 is an initial report from germany received on 07-jul-2022 from a consumer/other non health professional through diamed (de2095).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number ef0007, expiration date unknown) for menstrual pain, on unknown date.Concomitant medication was not reported.Medical history included menstrual pain and a tattoo.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The patient used thermacare heat wraps due to menstrual pain.She had a tattoo on her belly (older) and it burned there.Outcome: burn : unknown.The action taken with thermacare heat wraps in response to the event was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.Additional information was received from angelini s.P.A.On by bridges consumer healthcare on 29-jul-2022.Angelini s.P.A.Received the information on 18-jul-2022.The verbatim is as follows: product count: 2 count.Brand code/sku#: f00573302020w.Date of manufacture: 22-aug-2020 to 26-aug-2020.Expiry date: 07/2023.Quantity released: (b)(4) cartons.Batch ef0007 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Per (b)(4), consumer return samples and retain evaluations, effective 23-oct-2021, section 8.2: inspection of retain sample and retain evaluation was performed.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.(b)(6) retain sample inspection form documented the retain evaluation performed on 15-apr-2021 for a previous unrelated complaint.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 12.3.This result was below the upper control limit (ucl) of 76.2 complaints per (b)(4), complaint trending guideline, approved 29-apr-2021, version 6.0.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 attribute and variable 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 (b)(4), therapeutic heat wrap/lower abdomen/thermacare menstrual ii, effective date: 03-dec-2019.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.Based on the information provided, the event burn as described in this case is 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 menstrual mentions that burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse eventmedical device is plausible.Based on the information provided the causal relationship between thermacare menstrual and event is considered as possible.Batch ef0007 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attribute and variable 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 (b)(4), therapeutic heat wrap/lower abdomen/thermacare menstrual ii, effective date: 03-dec-2019.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.

• Brand Name: THERMACARE MENSTRUAL HEAT WRAP
• 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: 15055867
• MDR Text Key: 296171814
• Report Number: 3007593958-2022-00047
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

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 Lot Number: EF0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/18/2022; 08/17/2022
• Supplement Dates FDA Received: 08/01/2022; 09/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female