MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Cellulitis (1768); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Skin Inflammation (2443); Skin Tears (2516); Tissue Breakdown (2681)

Event Date 06/01/2016

Event Type  Injury  

Event Description

Cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful [cellulitis], fever [pyrexia], it was horrible.Poking me and rough [device issue].Case narrative: this is a spontaneous report from a contactable consumer reported for self.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date in (b)(6) 2016 (reported as a week ago) for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient wanted to know if the company changed the material where the velcro was, mentioned as "it was horrible.Poking me and rough and itchy.The heat helped, but that area left 3 small open sores on my abdomen.The sores have not healed and the area is red and puffy.They are tiny but ridiculously painful.As a healthy adult, i assume they will heal, or i will see a doctor.But, in a compromised person, sores like these could be a big issue in an area that is covered and not able to get air.I have used these before and they were so soft and comfortable".The patient had fever and cellulitis where the belt caused these small open wounds.She saw a doctor on (b)(6) 2016 and was being treated with an unspecified antibiotic.Events occurred on an unspecified date in (b)(6) 2016.Clinical outcome of the event cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful was not resolved.Clinical outcome of the remaining events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (09jun2016): new information reported from a contactable consumer included: new events (small open wounds, fever and cellulitis), the case was upgraded to serious, and event treatment.Follow-up (25aug2016): follow-up attempts are completed.No further information is expected.Follow-up (07jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the events fever and cellulitis described as 3 small open sores on abdomen, itchy, red and puffy, painful were considered serious bodily injury requiring intervention to prevent serious outcome, and/or permanent damage or impairment of body structure.The reported device issue was assessed as non-serious.The events were assessed as associated, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.Comment: based on the available information, the events fever and cellulitis described as 3 small open sores on abdomen, itchy, red and puffy, painful were considered serious bodily injury requiring intervention to prevent serious outcome, and/or permanent damage or impairment of body structure.The reported device issue was assessed as non-serious.The events were assessed as associated, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.

Manufacturer Narrative

Site sample status: not received.Complaint confirmed unique: not confirmed.Conclusion: evaluation of complaints related to non-defect subclass: 1.Introduction: 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) 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.2.Complaint handling for non-defect subclass: 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; 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.

Event Description

Event verbatim [preferred term].Cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful [cellulitis], fever [pyrexia], it was horrible.Poking me and rough [device issue].Narrative: this is a spontaneous report from a contactable consumer reported for self.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date in (b)(6) 2016 (reported as a week ago) for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient wanted to know if the company changed the material where the velcro was, mentioned as "it was horrible.Poking me and rough and itchy.The heat helped, but that area left 3 small open sores on my abdomen.The sores have not healed and the area is red and puffy.They are tiny but ridiculously painful.As a healthy adult, i assume they will heal, or i will see a doctor.But, in a compromised person, sores like these could be a big issue in an area that is covered and not able to get air.I have used these before and they were so soft and comfortable".The patient had fever and cellulitis where the belt caused these small open wounds.She saw a doctor on (b)(6) 2016 and was being treated with an unspecified antibiotic.Events occurred on an unspecified date in (b)(6) 2016.Clinical outcome of the event "cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful" and "it was horrible.Poking me and rough" was not resolved.Clinical outcome of the remaining event fever was unknown.According to product quality complaint group: site sample status: not received.Complaint confirmed unique: not confirmed.Conclusion: evaluation of complaints related to non-defect subclass: 1.Introduction: 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) 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.2.Complaint handling for non-defect subclass: 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; 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.Follow-up (09jun2016): new information reported from a contactable consumer included: new events (small open wounds, fever and cellulitis), the case was upgraded to serious, and event treatment.Follow-up (25aug2016): follow-up attempts are completed.No further information is expected.Follow-up (07jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (01may2020): new information received from product quality complaint group includes investigation results.

Manufacturer Narrative

Site sample status: not received.Complaint confirmed unique: not confirmed.Conclusion: evaluation of complaints related to non-defect subclass: 1.Introduction: 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) 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.2.Complaint handling for non-defect subclass: 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; 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.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion was as follows the root cause category is non-assignable (complaint not confirmed as a quality defect).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.A lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term], cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful [cellulitis], fever [pyrexia], it was horrible.Poking me and rough [device issue], narrative: this is a spontaneous report from a contactable consumer reported for self.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date in (b)(6) 2016 (reported as a week ago) for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient wanted to know if the company changed the material where the velcro was, mentioned as "it was horrible.Poking me and rough and itchy.The heat helped, but that area left 3 small open sores on my abdomen.The sores have not healed and the area is red and puffy.They are tiny but ridiculously painful.As a healthy adult, i assume they will heal, or i will see a doctor.But, in a compromised person, sores like these could be a big issue in an area that is covered and not able to get air.I have used these before and they were so soft and comfortable".The patient had fever and cellulitis where the belt caused these small open wounds.She saw a doctor on (b)(6) 2016 and was being treated with an unspecified antibiotic.Events occurred on an unspecified date in (b)(6) 2016.Clinical outcome of the event "cellulitis, 3 small open sores on abdomen, itchy, red and puffy, painful" and "it was horrible.Poking me and rough" was not resolved.Clinical outcome of the remaining event fever was unknown.According to product quality complaint group: site sample status: not received.Complaint confirmed unique: not confirmed.Conclusion: evaluation of complaints related to non-defect subclass: 1.Introduction: 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) 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.2.Complaint handling for non-defect subclass: 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; 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.According to product quality complaint group, reasonably suggest device malfunction was no.Severity of harm was not applicable.Site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion was as follows the root cause category is non-assignable (complaint not confirmed as a quality defect).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.A lot trend was not performed as the lot number is unknown.Follow-up (09jun2016): new information reported from a contactable consumer included: new events (small open wounds, fever and cellulitis), the case was upgraded to serious, and event treatment.Follow-up (25aug2016): follow-up attempts are completed.No further information is expected.Follow-up (07jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (01may2020): new information received from product quality complaint group includes investigation results.Follow-up (20mar2020): new information received from product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257095
• MDR Text Key: 180716520
• Report Number: 1066015-2019-00258
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention