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

Lot Number L72537

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Contusion (1787)

Event Date 07/02/2016

Event Type  Injury  

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.

Event Description

Patch extremely sticks and even leaves bruises [contusion], patch extremely sticks and even leaves bruises [device adhesion issue].Case narrative:this is a spontaneous report from a contactable pharmacist.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number l72537, expiration date apr2018, from an unspecified date for tension in back area.Mild tension in back area occurred from (b)(6) 2016 until (b)(6) 2016.The patient medical history was none, patient reported no anamnesis.The patient's concomitant medications were not reported.The patient reported thermacare was used before and tolerated.It was reported thermacare neck patch extremely stuck more than usual and even left bruises on (b)(6) 2016.The second patch from the same package was tolerated well, not affected.Action taken with the suspect product was unknown.Event was occurred on (b)(6) 2016 with outcome of resolved on (b)(6) 2016.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.Follow-up (26jul2016): new information from contactable pharmacist included: patient's age, event onset date/stop date.Product indication, no lab test done, follow-up attempts are completed.No further information is expected.Follow up (04aug2016): new information received from the product quality complaints group included lot number and investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (07jul2016): 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 event of "thermacare neck patch extremely stuck more than usual and even left bruises" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.This case will be re-assessed upon receipt of additional information., comment: based on the information provided, the event of "thermacare neck patch extremely stuck more than usual and even left bruises" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.This case will be re-assessed upon receipt of additional information.

Event Description

Event verbatim [preferred term] patch extremely sticks and even leaves bruises [contusion] , patch extremely sticks and even leaves bruises [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A 62-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number l72537, expiration date apr2018, from an unspecified date for tension in back area.Mild tension in back area occurred from (b)(6) 2016.The patient medical history was none, patient reported no anamnesis.The patient's concomitant medications were not reported.The patient reported thermacare was used before and tolerated.It was reported thermacare neck patch extremely stuck more than usual and even left bruises on (b)(6) 2016.The second patch from the same package was tolerated well, not affected.Action taken with the suspect product was unknown.Event was occurred on (b)(6) 2016 with outcome of resolved on (b)(6) 2016.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.Additional information has been requested and will be provided as it becomes available.Follow-up (26jul2016): new information from contactable pharmacist included: patient's age, event onset date/stop date.Product indication, no lab test done, follow up (04aug2016): new information received from the product quality complaints group included lot number and investigational results.Follow-up (07jul2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (23dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment: based on the information provided, the event of "thermacare neck patch extremely stuck more than usual and even left bruises" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.This case will be re-assessed upon receipt of additional information., comment: based on the information provided, the event of "thermacare neck patch extremely stuck more than usual and even left bruises" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.This case will be re-assessed upon receipt of additional information.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.

Event Description

Event verbatim [preferred term] patch extremely sticks and even leaves bruises [contusion] , patch extremely sticks and even leaves bruises [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A 62-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number l72537, expiration date apr2018, from an unspecified date for tension in back area.Mild tension in back area occurred from (b)(6) 2016.The patient medical history was none, patient reported no anamnesis.The patient's concomitant medications were not reported.The patient reported thermacare was used before and tolerated.It was reported thermacare neck patch extremely stuck more than usual and even left bruises on (b)(6) 2016.The second patch from the same package was tolerated well, not affected.Action taken with the suspect product was unknown.Event was occurred on (b)(6) 2016 with outcome of resolved on (b)(6) 2016.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.Follow-up (26jul2016): new information from contactable pharmacist included: patient's age, event onset date/stop date.Product indication, no lab test done.Follow up (04aug2016): new information received from the product quality complaints group included lot number and investigational results.Follow-up (07jul2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (23dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (24feb2020): this follow up is being submitted as a final report as investigations are completed and closed., comment: based on the information provided, the events of "thermacare neck patch extremely stuck more than usual and even left bruises" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed).There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The return sample does not provide any addition information as to why the wrap would have a "strong stick".Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The root cause of why the alleged wrap has a "strong stick" is inconclusive since review of records does not provide evidence to support defective product.

• 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: 9259549
• MDR Text Key: 184871968
• Report Number: 1066015-2019-00381
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

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
• Device Expiration Date: 04/01/2018
• Device Lot Number: L72537
• Was Device Available for Evaluation?: Yes
• 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: 12/26/2019; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR