MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problem Difficult to Remove (1528)

Patient Problems Bruise/Contusion (1754); Contusion (1787); Pain (1994)

Event Type  Injury  

Event Description

Trying to remove the product was extremely painful, left with a large bruise, the adhesive part would not come off/it was hurtful [contusion] , left with a large bruise on my shoulder area/the adhesive part would not come off [device adhesion issue],.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient recently used the above product.Trying to remove the product was extremely painful.The adhesive part would not come off.When she was able to finally remove it she was left with a large bruise on her shoulder area on an unspecified date.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Follow-up attempts are completed.No further information is expected.Follow-up (30mar2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events contusion and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events contusion and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] trying to remove the product was extremely painful, left with a large bruise, the adhesive part would not come off/it was hurtful [contusion] , left with a large bruise on my shoulder area/the adhesive part would not come off [device adhesion issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient recently used the above product.Trying to remove the product was extremely painful.The adhesive part would not come off.When she was able to finally remove it she was left with a large bruise on her shoulder area on an unspecified date.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to product quality complaint group: per site: rsnbly suggest device malfunction was yes and severity of harm was s1 for sub-class: adhesion/fastening defect.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 adhesion/fastening defect.Conclusion: 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 adhesion/fastening defect.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.Pr state was closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up attempts are completed.No further information is expected.Follow-up (30mar2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24jan2020): new information received from product quality complaints group included: investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events contusion and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 adhesion/fastening defect.No further investigations or actions are suggested at this time.Comment: based on the information provided, the events contusion and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 adhesion/fastening defect.No further investigations or actions are suggested at this time.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 adhesion/fastening defect.Conclusion: 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 adhesion/fastening defect.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.Pr state was closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 adhesion/fastening defect.Conclusion: 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 adhesion/fastening defect.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.Pr state was closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.Conclusion: 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term] trying to remove the product was extremely painful, left with a large bruise, the adhesive part would not come off/it was hurtful [contusion], left with a large bruise on my shoulder area/the adhesive part would not come off [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient recently used the above product.Trying to remove the product was extremely painful.The adhesive part would not come off.When she was able to finally remove it she was left with a large bruise on her shoulder area on an unspecified date.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to product quality complaint group: per site: severity of harm was s1 for sub-class: adhesion/fastening defect.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 adhesion/fastening defect.Conclusion: 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 adhesion/fastening defect.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.Pr state was closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Additional information received from product quality complaint (pqc) group included investigation results for subclass: adverse event safety request for investigation.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.Conclusion: 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6)2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24jan2020): new information received from product quality complaints group included: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2020): new information received from product quality complaints group included: investigation results.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9259542
• MDR Text Key: 184810741
• Report Number: 1066015-2019-00379
• 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: 03/30/2016

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/07/2020; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention