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

Lot Number AM1737

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

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

Event Type  malfunction  

Event Description

Heat wraps were already warm and black stuff came out [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.The pharmacist reported on thermacare heatwrap (thermacare lower back & hip), device lot number am1737, expiration date dec2021.It was reported that several heat wraps were already warm and black stuff came out.Four packages were affected.The action taken with thermacare heatwrap and the outcome of the event was not reported.Per the product quality group, the severity of harm was s3.Company clinical evaluation comment: based on the information provided, it was reported that heat wraps were already warm and black stuff came out.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: based on the information provided, it was reported that heat wraps were already warm and black stuff came out.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data 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.

Event Description

Event verbatim [preferred term] heat wraps were already warm and black stuff came out [device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist.The pharmacist reported on thermacare heatwrap (thermacare lower back & hip), device lot number am1737, expiration date dec2021.It was reported that several heat wraps were already warm and black stuff came out.Four packages were affected.The pharmacist confirmed that no undesired effects occurred.The action taken with thermacare heatwrap and the outcome of the event was not reported.Per the product quality group, the severity of harm was s3.Investigation conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data 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.Follow-up (04mar2020 and 11mar2020): new information from product quality complaints includes: investigation results; and from the same contactable pharmacist: confirmation that no undesired effects occurred.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, it was reported that heat wraps were already warm and black stuff came out.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The event is 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 remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] heat wraps were already warm and black stuff came out [device leakage], , narrative: this is a spontaneous report from a contactable pharmacist.The pharmacist reported on thermacare heatwrap (thermacare lower back & hip), device lot number am1737, expiration date dec2021.It was reported that several heat wraps were already warm and black stuff came out.Four packages were affected.The pharmacist confirmed that no undesired effects occurred.The action taken with thermacare heatwrap and 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- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: batch am1737 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data 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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the albany 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 7 was below the upper control limit (ucl) of 25.2 complaints per million produced per sop-105746, complaint trending guideline, effective 24-feb-2020.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.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.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status was not received.Follow-up ((b)(6) 2020): new information from product quality complaints includes: investigation results; and from the same contactable pharmacist: confirmation that no undesired effects occurred.Follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

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.Summary of investigation: batch am1737 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data 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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the albany 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 7 was below the upper control limit (ucl) of 25.2 complaints per million produced per sop-105746, complaint trending guideline, effective 24-feb-2020.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.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.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status was 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: 9728378
• MDR Text Key: 190154828
• Report Number: 1066015-2020-00045
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Lot Number: AM1737
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1