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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Urticaria (2278)

Event Type  Injury  

Event Description

"whelp" [urticaria], did not work [device ineffective] narrative: this is a spontaneous report from a non-contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Thermacare one did work and did not work and the last one cause "whelp" on her back.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the packaged product quality.Lot trend assmt.& rationale: no lot trend assessment preformed on unknown lot number.Exped trend assmt.& rationale: not an expedite complaint.Other trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on the root cause identified in (b)(4), there is not a trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused for lbh products, refer to attached trending chart unknown lbh wrap patch pad never workedcan not be reused 27-oct-2017 to 27-oct-2020.There is no further action is required.Site sample status: not received.

Event Description

Event verbatim [preferred term] "whelp" [urticaria], did not work [device ineffective], , narrative: this is a spontaneous report from a non-contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Thermacare one did work and did not work and the last one cause "whelp" on her back.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the packaged product quality.Lot trend assmt.& rationale: no lot trend assessment preformed on unknown lot number.Exped trend assmt.& rationale: not an expedite complaint.Other trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on the root cause identified in (b)(4), there is not a trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused for lbh products, refer to attached trending chart unknown lbh wrap patch pad never workedcan not be reused 27-oct-2017 to 27-oct-2020.There is no further action is required.Site sample status: not received.Follow-up (24nov2020) new information received from a product complaint group included: investigation results.

Event Description

Event verbatim [preferred term] "whelp" [urticaria], did not work [device ineffective], , narrative: this is a spontaneous report from a non-contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Thermacare one did work and did not work and the last one cause "whelp" on her back.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the packaged product quality.Lot trend assmt.& rationale: no lot trend assessment preformed on unknown lot number.Exped trend assmt.& rationale: not an expedite complaint.Other trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on the root cause identified in (b)(4), there is not a trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused for lbh products, refer to attached trending chart unknown lbh wrap patch pad never workedcan not be reused 27-oct-2017 to 27-oct-2020.There is no further action is required.Site sample status: not received.According to device complaint handling unit (dchu): severity of harm was s3.Follow-up (24nov2020): new information received from a product complaint group included: investigation results.Follow-up (23jan2021): new information received from device complaint handling unit (dchu) included: severity of harm.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the packaged product quality.Lot trend assmt.& rationale: no lot trend assessment preformed on unknown lot number.Exped trend assmt.& rationale: not an expedite complaint.Other trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on the root cause identified in (b)(4), there is not a trend identified for the subclass wrap/patch/pad never worked/unusable/can not be reused for lbh products, refer to attached trending chart unknown lbh wrap patch pad never workedcan not be reused 27-oct-2017 to 27-oct-2020.There is no further action is required.Site sample status: not received.

• 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: 10809862
• MDR Text Key: 215322284
• Report Number: 1066015-2020-00187
• 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: 10/27/2020

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: 11/09/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2020; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention