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

Lot Number BK2631

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

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term] one of the wraps was ripped [device breakage], narrative: this is a spontaneous report from a contactable consumer (patient).This consumer reported two devices.This is the first of 2 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number bk2631, expiration date jan2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient opened thermacare backpain therapy l/xl.One of the wraps was ripped.The action taken in response for the event and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Lot number provided determined to be invalid as per sap/site.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour effective date: (b)(6) 2020.Investigation conducted for unknown lot number lower back/hip (lbh) product.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.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: (b)(6) 2018 through 09feb2021 / manufacturing site: pfizer (site name withheld)/complaint class: product appearance /complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 21 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.None of the complaints 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 unknown heat cells leaking (b)(6) 2018 to (b)(6) 2021.No further action is required.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 product.No further action is required.Sample status at the site was not returned.Additional investigation results from product quality complaints for subclass came apart/separated/torn (excludes damaged cells) includes: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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 came apart/separated/torn (excludes damaged cells).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.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) search was performed: scope: date contacted (b)(6) 2018 through (b)(6) 2021/manufacturing site: pfizer (site name withheld)/complaint class: product appearance/complaint subclass heat cells damaged/leaking).The citi search returned a total of 175 complaints for lower back/hip(lbh) 8 hour products during this time period for the class/subclass.Five of the 175 complaints were confirmed as having a manufacturing process root cause for a complaint of came apart/separated/torn (excludes damaged cells).A citi complaint trend search was conducted for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8 hr products.The data shows a seasonality increase in (b)(6) 2018, (b)(6) 2018, and (b)(6) 2020.The data shows a spike in complaints in (b)(6) 2019.Seven of 13 of the complaints received in (b)(6) 2019 were for an unknown lot number.The data did not show an increase over time (36 months).No trend identified for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8hr products.There is no further action required.Exped trend actions taken: there is no trend identified for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8hr products.There is no further action required.Return sample evaluation: a return sample has not been received at the site as of (b)(6) 2021.

Event Description

Event verbatim [preferred term]: one of the wraps was ripped [device breakage], had the heat cells open [device leakage].Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number bk2631, expiration date jan2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient opened thermacare backpain therapy l/xl.One of the wraps was ripped the other one had the heat cells open.The action taken in response for the event and event outcome was unknown.According to product quality complaint, the following investigation information was provided for subclass heat cells damaged/leaking: lot number provided determined to be invalid as per sap/site.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour effective date: (b)(6) 2020.Investigation conducted for unknown lot number lower back/hip (lbh) product.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.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.An evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: (b)(6) 2018 through (b)(6) 2021/manufacturing site: pfizer (site name withheld)/complaint class: product appearance/complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 21 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.None of the complaints 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 unknown heat cells leaking (b)(6) 2018 to (b)(6) 2021.No further action is required.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 product.No further action is required.Sample status at the site was not returned.Additional investigation results from product product quality complaints for subclass came apart/separated/torn (excludes damaged cells) includes: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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 came apart/separated/torn (excludes damaged cells).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.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) search was performed: scope: date contacted (b)(6) 2018 through (b)(6) 2021/manufacturing site: pfizer (site name withheld)/complaint class: product appearance/complaint subclass heat cells damaged/leaking).The citi search returned a total of 175 complaints for lower back/hip(lbh) 8 hour products during this time period for the class/subclass.Five of the 175 complaints were confirmed as having a manufacturing process root cause for a complaint of came apart/separated/torn (excludes damaged cells).A citi complaint trend search was conducted for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8 hr products.The data shows a seasonality increase in (b)(6) 2018, (b)(6) 2018, and (b)(6) 2020.The data shows a spike in complaints in (b)(6) 2019.Seven of 13 of the complaints received in (b)(6) 2019 were for an unknown lot number.The data did not show an increase over time (36 months).No trend identified for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8hr products.There is no further action required.Exped trend actions taken: there is no trend identified for the subclass came apart/separated/torn (excludes damaged cells) for lbh 8hr products.There is no further action required.Return sample evaluation: a return sample has not been received at the site as of (b)(6) 2021.Follow-up (11feb2021,12feb2021, 22feb2021, and 02mar2021): new information received by pfizer from angelini pharma, license party for thermacare and from product quality complaints includes: investigation results(subclass heat cells damaged/leaking).Follow-up (11feb2021 and 05mar2021) this is a follow-up report combining information from duplicate reports 2021161060 and 2021161030.The current and all subsequent information will be reported under manufacturer report number 2021161030.New information reported from a contactable consumer (patient) includes: updated events (heat cells open).New information reported from product quality complaintson 05mar2021 includes: investigation results (came apart/separated/torn (excludes damaged cells)).

• 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: 11401559
• MDR Text Key: 264066519
• Report Number: 1066015-2021-00026
• 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
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Lot Number: BK2631
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1