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

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

They said they were leaking so she thought these must be leaking too [device leakage], narrative: this is a spontaneous report from a contactable consumer.An unspecified number of patients started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] they said they were leaking so she thought these must be leaking too [device leakage], narrative: this is a spontaneous report from a contactable consumer.An unspecified number of patients started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint: severity of harm was s3.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow up (11dec2020): new information received from the product quality complaint group includes severity ranking assessment; this follow-up report is also being submitted to amend previously reported information:suspect product was recoded to thermacare neck, shoulder & wrist.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number nsw 8hr 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 product quality related trend identified for the subclass wrap/patch/pad too hot.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 wrap/patch/pad too hot.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.N/a an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search performed: scope: date contacted: 23oct2017 through 23oct2020, manufacturing site: pfizer albany/complaint class: product use attributes, complaint sub class: wrap/patch/pad too hot.The citi customizable search returned a total of 27 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None of the 27 was confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.The data did not show an increase overtime (36 months).Based on this evaluation, there is not a trend identified for the subclass of wrap/patch/pad too hot.For neck/shoulder/wrist (nsw) 8hr.Refer to the attached 36-month trend chart for nsw 8hr too hot (b)(6) 2017 to (b)(6) 2020.There is no further action required.Exped trend actions taken: based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status: not received.

Event Description

Event verbatim [preferred term], they said they were leaking so she thought these must be leaking too [device leakage], narrative: this is a spontaneous report from a contactable consumer.An unspecified number of patients started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint: severity of harm was s3.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Additionally the complaint group reported that: summary of investigation: this investigation was conducted for an unknown lot number nsw 8hr 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 product quality related trend identified for the subclass wrap/patch/pad too hot.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 wrap/patch/pad too hot.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search performed: scope: date contacted: 23oct2017 through 23oct2020, manufacturing site: pfizer albany/complaint class: product use attributes, complaint sub class: wrap/patch/pad too hot.The citi customizable search returned a total of 27 complaints for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.None of the 27 was confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.The data did not show an increase overtime (36 months).Based on this evaluation, there is not a trend identified for the subclass of wrap/patch/pad too hot.For neck/shoulder/wrist (nsw) 8hr.Refer to the attached 36-month trend chart for nsw 8hr too hot (b)(6) 2017 to (b)(6) 2020.There is no further action required.Exped trend actions taken: based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status: not received follow up (11dec2020): new information received from the product quality complaint group includes severity ranking assessment; this follow-up report is also being submitted to amend previously reported information:suspect product was recoded to thermacare neck, shoulder & wrist.Follow up (21dec2020): follow up attempts completed, no further information expected.Follow-up (15dec2020): new information received from the product quality complaint group includes: investigation results.Follow up attempts are completed.No further information is expected.

Event Description

Event verbatim [preferred term].They said they were leaking so she thought these must be leaking too [device leakage], , narrative: this is a spontaneous report from a contactable consumer.An unspecified number of patients started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated she was looking for the number before in (b)(6)2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint: severity of harm was s3.There is reasonable suspicion of a device malfunction.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 or a 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/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Summary of investigation: this investigation was conducted for an unknown lot number nsw 8-hour product.There was limited device-specific information provided, and no batch number or return sample was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is no product quality-related trend identified for the subclass heat cells damaged/leaking.Follow up ((b)(6)2020): new information received from the product quality complaint group includes severity ranking assessment; this follow-up report is also being submitted to amend previously reported information:suspect product was recoded to thermacare neck, shoulder & wrist.Follow up ((b)(6) 2020): follow up attempts completed, no further information expected.Follow-up ((b)(6) 2020): new information received from the product quality complaint group includes: investigation results.Follow up attempts are completed.No further information is expected.Follow-up ((b)(6) 2021): new information received from the product quality complaint group includes: investigation summary.Follow up attempts are completed.No further information is expected.

Manufacturer Narrative

There is reasonable suspicion of a device malfunction.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 or a 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/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Summary of investigation: this investigation was conducted for an unknown lot number nsw 8-hour product.There was limited device-specific information provided, and no batch number or return sample was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is no product quality-related trend identified for the subclass heat cells damaged/leaking.

• 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: 10816464
• MDR Text Key: 250323447
• Report Number: 1066015-2020-00190
• 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,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• 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