MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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

Patient Problems Dyspnea (1816); Reaction (2414)

Event Date 02/24/2016

Event Type  Injury  

Event Description

Anaphylactic reaction [anaphylactic reaction] allergic reaction [hypersensitivity] throat got tight [throat tightness] her hands turned blue [skin discolouration] a hard time breathing.[dyspnoea] case description: this is a spontaneous report from a contactable nurse reported for daughter.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare menstrual) , on (b)(6) 2016 for menstrual cramps.Medical history included allergy to latex and peanuts from an unknown date and unknown if ongoing.No known drug allergies.The patient's concomitant medications were none.Patient put the heat wrap at work around 10am on (b)(6) 2016, at 3:30pm, her throat got tight and her hands turned blue.Her coworker drove her to the emergency room (er).By the time they got to the er, patient was having a hard time breathing.Described as an anaphylactic reaction.In the er, patient took off the thermacare menstrual wrap.She wondered if it had latex in it based on how it was stuck to her.The doctor gave her an anaphylaxis cocktail; iv benadryl, pepcid, prednisone, and they used a hospital epipen.The doctor said it was one dose of everything.One minute after the medicine was given, the symptoms resolved on (b)(6) 2016.They are trying to figure what caused the allergic reaction.The thermacare was the only thing different, she did not eat anything different.In the er, they drew blood to check her eosinophils.They drew a cbc and everything was normal.Consumer wants to know if product contains latex.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events anaphylactic reaction, hypersensitivity, dyspnea, throat tightness, and skin discoloration as described in this case represent a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events anaphylactic reaction, hypersensitivity, dyspnea, throat tightness, and skin discoloration as described in this case represent a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaints received at the site in the global complaint database related to non-defect will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release, and there is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.The samples received at the site for these subclasses are evaluated per sop- consumer return samples and retain evaluations.The assessment is documented on form- returned consumer sample evaluation.A sample was not received at the site.Product quality complaints provided the following investigation information for complaint sub-class: adverse event safety request for investigation: there was no reasonable suggestion of device malfunction.A sample was not received at the site.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour 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.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "it does not say latex free or contains latex." thermacare heatwrap products do not contain latex.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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.

Event Description

Event verbatim [preferred term] anaphylactic reaction [anaphylactic reaction], allergic reaction [hypersensitivity], throat got tight [throat tightness], her hands turned blue [skin discolouration], a hard time breathing.[dyspnoea].Narrative: this is a spontaneous report from a contactable nurse reported for daughter.A 23-years-old female patient started to receive thermacare heatwrap (thermacare menstrual) , on (b)(6) 2016 for menstrual cramps.Medical history included allergy to latex and peanuts from an unknown date and unknown if ongoing.No known drug allergies.The patient's concomitant medications were none.Patient put the heat wrap at work around 10am on (b)(6) 2016, at 3:30pm, her throat got tight and her hands turned blue.Her coworker drove her to the emergency room (er).By the time they got to the er, patient was having a hard time breathing.Described as an anaphylactic reaction.In the emergency room, patient took off the thermacare menstrual wrap.She wondered if it had latex in it based on how it was stuck to her.The doctor gave her an anaphylaxis cocktail; iv benadryl, pepcid, prednisone, and they used a hospital epipen.The doctor said it was one dose of everything.One minute after the medicine was given, the symptoms resolved on (b)(6) 2016.They are trying to figure what caused the allergic reaction.The thermacare was the only thing different, she did not eat anything different.In the emergency room, they drew blood to check her eosinophils.They drew a cbc and everything was normal.Consumer wants to know if product contains latex.Product quality complaints provided the following investigation information for complaints related to non-defect subclass: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaints received at the site in the global complaint database related to non-defect will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release, and there is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.The samples received at the site for these subclasses are evaluated per sop- consumer return samples and retain evaluations.The assessment is documented on form- returned consumer sample evaluation.A sample was not received at the site.Product quality complaints provided the following investigation information for complaint sub-class: adverse event safety request for investigation: there was no reasonable suggestion of device malfunction.A sample was not received at the site.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour 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.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "it does not say latex free or contains latex." thermacare heatwrap products do not contain latex.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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (29apr2016): follow-up attempts completed.No further information expected.Amendment: this follow-up is being submitted to provide product quality investigation results (non-defect subclass) with a receipt date of 06jul2020.Additionally, the following new information was received from product quality complaints on 14aug2020 and 17aug2020: additional investigation results (subclass adverse event safety request for investigation).Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events anaphylactic reaction, hypersensitivity, dyspnea, throat tightness, and skin discoloration as described in this case represent a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5479991
• MDR Text Key: 39687049
• Report Number: 1066015-2016-00038
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: 02/25/2016
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 64