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

Lot Number AD3849

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Event verbatim [preferred term] indication: degenerative disc disease [intentional device misuse] , viral infection [viral infection].Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number ad3849, expiration date oct2021, via an unspecified route of administration from an unspecified date and ongoing at unknown dose for degenerative disc disease and pain.Medical history included degenerative disc disease, and back surgery.Concomitant medication was none.Consumer had used this product for years.She had degenerative disc disease.She confirmed this was diagnosed prior to use.She had back surgery- a very failed one- and started using this product after.She had a terrible time purchasing this product.She could not find the heat wrap in a l/xl in (pharmacy name) in her area in (city name).She thought they must have a problem with product.She was traveling north to (state name) around (b)(6) 2019 and she stopped in a pharmacy in (state name).She believed this was where she purchased this particular package from.She went to use the product and there was no sticky (adhesive) on the ends the heat wrap just fell off.The patient was not hospitalized nor given treatment for this.She confirms this heat wrap was for back pain therapy.She mentioned she had a viral infection on (b)(6) 2019.She was improving and should be recovered within the next 3-4 weeks.She believed she started using thermacare heat wraps back in the 1980's.This would be her guess.She used the product for her back particularly when she was traveling.She waited so long to find the product and finally when she got caught up with the product (had the product, this was what she found).The patient was hospitalized for "indication: degenerative disc disease" and was given treatment and had not recovered from the event.The action taken in response to the events of the product was unknown.The outcome of viral infection was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2019): new information received from a contactable consumer includes: product information (added indication) and reaction data (added seriousness of hospitalization and treatment).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that "indication: degenerative disc disease" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.Event viral infection is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the available information, the patient reported that "indication: degenerative disc disease" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.Event viral infection is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Indication: degenerative disc disease [intentional device misuse] , viral infection [viral infection].Case narrative: this is a spontaneous report from a contactable consumer.This 70-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number ad3849, expiration date oct2021, via an unspecified route of administration from an unspecified date and ongoing at unknown dose for degenerative disc disease and pain.Medical history included degenerative disc disease, and back surgery.Concomitant medication was none.Consumer had used this product for years.She had degenerative disc disease.She confirmed this was diagnosed prior to use.She had back surgery- a very failed one- and started using this product after.She had a terrible time purchasing this product.She could not find the heat wrap in a l/xl in (pharmacy name) in her area in (city name).She thought they must have a problem with product.She was traveling north to (state name) around (b)(4).2019 and she stopped in a pharmacy in (state name).She believed this was where she purchased this particular package from.She went to use the product and there was no sticky (adhesive) on the ends the heat wrap just fell off.The patient was not hospitalized nor given treatment for this.She confirms this heat wrap was for back pain therapy.She mentioned she had a viral infection on 05may2019.She was improving and should be recovered within the next 3-4 weeks.She believed she started using thermacare heat wraps back in the 1980's.This would be her guess.She used the product for her back particularly when she was traveling.She waited so long to find the product and finally when she got caught up with the product (had the product, this was what she found).The patient was hospitalized for "indication: degenerative disc disease" and was given treatment and had not recovered from the event.The action taken in response to the events of the product was unknown.The outcome of viral infection was resolving.According to product quality complaint group, the severity ranking was assessed as s1.Follow-up (03sep2019): new information received from a contactable consumer includes: product information (added indication) and reaction data (added seriousness of hospitalization and treatment).Follow-up attempts are completed.No further information is expected.Follow-up (17oct2019): new information received from product quality complaint group included: severity ranking was assessed as s1.Company clinical evaluation comment: based on the available information, the patient reported that "indication: degenerative disc disease" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.Event viral infection is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the available information, the patient reported that "indication: degenerative disc disease" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.Event viral infection is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] indication: degenerative disc disease [intentional device misuse] , viral infection [viral infection].Case narrative:this is a spontaneous report from a contactable consumer.This 70-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number ad3849, expiration date 31oct2021, via an unspecified route of administration from an unspecified date and ongoing at unknown dose for degenerative disc disease and pain.Medical history included degenerative disc disease, and back surgery.Concomitant medication was none.Consumer had used this product for years.She had degenerative disc disease.She confirmed this was diagnosed prior to use.She had back surgery- a very failed one- and started using this product after.She had a terrible time purchasing this product.She could not find the heat wrap in a l/xl in (pharmacy name) in her area in (city name).She thought they must have a problem with product.She was traveling north to (state name) around (b)(6) 2019 and she stopped in a pharmacy in (state name).She believed this was where she purchased this particular package from.She went to use the product and there was no sticky (adhesive) on the ends the heat wrap just fell off.The patient was not hospitalized nor given treatment for this.She confirms this heat wrap was for back pain therapy.She mentioned she had a viral infection on (b)(6) 2019.She was improving and should be recovered within the next 3-4 weeks.She believed she started using thermacare heat wraps back in the 1980's.This would be her guess.She used the product for her back particularly when she was traveling.She waited so long to find the product and finally when she got caught up with the product (had the product, this was what she found).The patient was hospitalized for "indication: degenerative disc disease" and was given treatment and had not recovered from the event.The action taken in response to the events of the product was unknown.The outcome of viral infection was resolving.According to product quality complaint group, the severity ranking was assessed as s1.Product investigation results were as follows: document review summary: batch ad3849 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables, quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met, hook shear hang test measures wrap hook and landing zone bonding by using a known weight to pull on the hook/landing zone bonds in a shear mode.If the hook/landing zone bonds stay intact per the release requirements, the wrap passes.There were no failures of the hook shear hang test recorded for the batch.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving fastening defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the no lot trend identified.First complaint for the sub class adhesion/fastening defect received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 4 was below the upper control limit (ucl) of 189.5 complaints.On this basis, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.The review of the device history record for the batch does not provide evidence to support defective product, there were no defects recorded for the batch.Our manufacturing operations employ quality control procedures which include in-process testing, 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 product quality for the batch is not impacted by this complaint.Site sample status was not received.Follow-up (03sep2019): new information received from a contactable consumer includes: product information (added indication) and reaction data (added seriousness of hospitalization and treatment).Follow-up attempts are completed.No further information is expected.Follow-up (17oct2019): new information received from product quality complaint group included: severity ranking was assessed as s1.Follow-up (28feb2020): new information received from product quality complaints includes product investigation summary.Comment: based on the available information, the patient reported that "indication: degenerative disc disease" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.Event viral infection is non-serious.The events are medically assessed as associated with the use of the device.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.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Document review summary: batch ad3849 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables, quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met, hook shear hang test measures wrap hook and landing zone bonding by using a known weight to pull on the hook/landing zone bonds in a shear mode.If the hook/landing zone bonds stay intact per the release requirements, the wrap passes.There were no failures of the hook shear hang test recorded for the batch.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving fastening defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the no lot trend identified.First complaint for the sub class adhesion/fastening defect received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 4 was below the upper control limit (ucl) of 189.5 complaints.On this basis, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.The review of the device history record for the batch does not provide evidence to support defective product, there were no defects recorded for the batch.Our manufacturing operations employ quality control procedures which include in-process testing, to ensure the quality of the product being packaged.No quality issues were identify.

• 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: 9081668
• MDR Text Key: 163296011
• Report Number: 1066015-2019-00230
• 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: 08/12/2019

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: 10/31/2021
• Device Lot Number: AD3849
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/29/2019; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77