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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Event verbatim [preferred term]: i had one where it appeared that one of the heat cells was leaking or about to when i opened.I just tossed and got another.I use so often that was not worried about one not working (bad/leaking cell) [device leakage].Narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), from 2017 at about 3-4 times week, and from 2010 daily while working for lower back, and for both hips.The patient's medical history and concomitant medications were not reported.The patient stated several years ago she had one where it appeared that one of the heat cells was leaking or about to when she opened.She just tossed and got another as stuff happens.She used so often that she was not worried about one not working (bad/leaking cell) on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].I had one where it appeared that one of the heat cells was leaking or about to when i opened.I just tossed and got another.I use so often that was not worried about one not working (bad/leaking cell) [device leakage], narrative: this is a spontaneous report from a contactable consumer.An adult female patient started to receive thermacare heatwrap (thermacare lower back & hip), from 2017 at about 3-4 times week, and from 2010 daily while working for lower back, and for both hips.The patient's medical history and concomitant medications were not reported.The patient stated several years ago she had one where it appeared that one of the heat cells was leaking or about to when she opened.She just tossed and got another as stuff happens.She used so often that she was not worried about one not working (bad/leaking cell) on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: 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 (22jul2020): this is a follow up report from the product quality complaint group includes impact analysis, severity assessment and patient age removed.No follow-up attempts are needed.No further information is expected.

Event Description

Event verbatim [preferred term]: i had one where it appeared that one of the heat cells was leaking or about to when i opened.I just tossed and got another.I use so often that was not worried about one not working (bad/leaking cell) [device leakage].Narrative: this is a spontaneous report from a contactable consumer.An adult female patient started to receive thermacare heatwrap (thermacare lower back & hip), from 2017 at about 3-4 times week, and from 2010 daily while working for lower back, and for both hips.The patient's medical history and concomitant medications were not reported.The patient stated several years ago she had one where it appeared that one of the heat cells was leaking or about to when she opened.She just tossed and got another as stuff happens.She used so often that she was not worried about one not working (bad/leaking cell) on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: 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.Severity of harm was s3.Site sample status was not received.Summary of investigation: investigation conducted for unknown lot number lower back/hip (lbh) product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample available for evaluation.Without a batch reference number or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Scope: date of contact: 10jul2017.Manufacturing site: pfizer (site name) /complaint class: product appearance /complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 49 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Five of the 49 records were identified as having a manufacturing related root cause of the wrap having heat cells damaged/ leaking defects.Based on this citi search, there is not a trend identified for the subclass cells damaged/leaking and heat cells damaged/leaking for lbh 8hr products, refer to attached trending chart lbh heat cells damaged leaking (b)(6) 2017 to (b)(6) 2020.No further action is required.Follow-up (22jul2020): this is a follow up report from the product quality complaint group includes impact analysis, severity assessment and patient age removed.No follow-up attempts are needed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: device available for evaluation and current location of device updated.Amendment: this follow-up report is being submitted to amend previously reported information: "operator of device" was populated as "lay user".Follow-up (18sep2020): new information received from product quality complaint group includes investigation results.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

Severity of harm was s3.Site sample status was not received.Summary of investigation: investigation conducted for unknown lot number lower back/hip (lbh) product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample available for evaluation.Without a batch reference number or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Scope: date of contact: 10jul2017.Manufacturing site: pfizer (site name) /complaint class: product appearance /complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 49 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Five of the 49 records were identified as having a manufacturing related root cause of the wrap having heat cells damaged/ leaking defects.Based on this citi search, there is not a trend identified for the subclass cells damaged/leaking and heat cells damaged/leaking for lbh 8hr products, refer to attached trending chart lbh heat cells damaged leaking (b)(6) 2017 to (b)(6) 2020.No further action is required.

Event Description

Event verbatim [preferred term].I had one where it appeared that one of the heat cells was leaking or about to when i opened.I just tossed and got another.I use so often that was not worried about one not working (bad/leaking cell) [device leakage].Narrative: this is a spontaneous report from a contactable consumer.An adult female patient started to receive thermacare heatwrap (thermacare lower back & hip), from 2017 at about 3-4 times week, and from 2010 daily while working for lower back, and for both hips.The patient's medical history and concomitant medications were not reported.The patient stated several years ago she had one where it appeared that one of the heat cells was leaking or about to when she opened.She just tossed and got another as stuff happens.She used so often that she was not worried about one not working (bad/leaking cell) on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: 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 (22jul2020): this is a follow up report from the product quality complaint group includes impact analysis, severity assessment and patient age removed.No follow-up attempts are needed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: device available for evaluation and current location of device updated.

Event Description

Event verbatim [preferred term], i had one where it appeared that one of the heat cells was leaking or about to when i opened.I just tossed and got another.I use so often that was not worried about one not working (bad/leaking cell) [device leakage], narrative: this is a spontaneous report from a contactable consumer.An adult female patient started to receive thermacare heatwrap (thermacare lower back & hip), from 2017 at about 3-4 times week, and from 2010 daily while working for lower back, and for both hips.The patient's medical history and concomitant medications were not reported.The patient stated several years ago she had one where it appeared that one of the heat cells was leaking or about to when she opened.She just tossed and got another as stuff happens.She used so often that she was not worried about one not working (bad/leaking cell) on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: 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 (22jul2020): this is a follow up report from the product quality complaint group includes impact analysis, severity assessment and patient age removed.No follow-up attempts are needed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: device available for evaluation and current location of device updated.Amendment: this follow-up report is being submitted to amend previously reported information: "operator of device" was populated as "lay user".

• 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: 10309428
• MDR Text Key: 201922203
• Report Number: 1066015-2020-00150
• 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,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2020; 07/29/2020; 08/11/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 113