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

Lot Number Q01103

Device Problem Moisture Damage (1405)

Patient Problem Tingling (2171)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The consumer returned sample evaluation does not show any obvious defects.In general - as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak (not visible to naked eye) can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.Our 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.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.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-23451, effective date: 28jul2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.To improve the verification of pouch integrity there is one project in process and one just completed.The projects are listed below: pouch sealing-(name) equipment-was added to the flow wrapper on 10jan2017.It measures the sealing process of the flow wrapper.Pti replacement-(name) units will be replacing the pti units target date for completion is 2nd quarter of 2017.After a review of the leak data the batch in question did not have any leak results outside the release specifications.

Event Description

Hands tingly [paraesthesia], she had opened two of the three wraps from the last box and they were both wet [device physical property issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) 8 hour, device lot number q01103, expiration date jul2019, udi number: (b)(4), sap/unique identifier: (b)(4), from 23jan2017 at an unknown frequency for painful spot in right hip and low back pain.Medical history included hysterectomy in 2015, cholesterol and estrogen abnormal after hysterectomy.Concomitant medication included simvastatin for cholesterol orally at 40 mg once a day from (b)(6) 2015 and ongoing and estradiol orally at 2 mg once a day from (b)(6) 2015 and ongoing for estrogen after hysterectomy.The patient reported that inside two individually packaged thermacare lower back and hip heat wraps it was wet.She had purchased a package of three boxes of the thermacare product, with each box having three individually wrapped heat wraps.She used the heat wraps from the first two boxes and they were fine and not wet.She had opened two of the three wraps from the last box and they were both wet in (b)(6) 2017.She did not want to open the last heat wrap because her hands felt a little tingly after touching the wetness on (b)(6) 2017.No hospitalized involved and no treatment received for event hands tingly.The action taken with thermacare heatwrap was dose not changed.The device was available to be returned for evaluation.The outcomes of events were resolved in 2017.Product strength and count size dispensed: the box has three heat wraps inside of it size l/xl.Additional batch/lot numbers: next to the lot number is 08/06 and next to the expiration date is 12:12.The patient agreed to hold on to the two opened heat wraps that are wet as well as the unopened heat wrap from that box in case a prepaid (name) was sent out.Investigation summary of product quality complaint on 17mar2017 includes: the root cause category is non-assignable (complaint not confirmed).The consumer returned sample evaluation does not show any obvious defects.In general - as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak (not visible to naked eye) can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.Our 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.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.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-23451, effective date: 28jul2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.To improve the verification of pouch integrity there is one project in process and one just completed.The projects are listed below: pouch sealing-(name) equipment-was added to the flow wrapper on (b)(6) 2017.It measures the sealing process of the flow wrapper.Pti replacement-(name) units will be replacing the pti units target date for completion is 2nd quarter of 2017.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Additional information has been requested and will be provided as it becomes available.Follow-up (14feb2017): new information received from a contactable consumer reported in response to non-hcp letter sent which included that: device indication, concomitant drug information, event hospitalized and treatment information, event outcome and device action taken.Follow-up (17mar2017): new information received from a product quality complaint includes: additional information on product and product quality complaint.Follow-up (12apr2017): follow-up attempts are completed.No further information is expected.Follow-up (26jan2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events paraesthesia and device physical property issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events paraesthesia and device physical property issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9259574
• MDR Text Key: 185223899
• Report Number: 1066015-2019-00368
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010969
• UDI-Public: 305733010969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2017

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: 07/01/2019
• Device Lot Number: Q01103
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 73