MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number EC2269

Device Problems Insufficient Heating (1287); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2020

Event Type  malfunction  

Event Description

1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side [device breakage].Narrative: the initial case was missing the following minimum criteria: [no adverse effect].Upon receipt of follow-up information on [14dec2020], this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date jun2023, upc number: (b)(4),via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated he found on (b)(6) 2020 both wraps were rock hard.He put one of them on his neck, but it didn't heat up, so he didn't even try the other one.The 3rd wrap in the box was soft, so he used that one and it worked.The reporter stated that the corner of packaging was kind of funky.Clarified that 1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side.Agent provided lot number as bt2269, but caller stated that it was ec2269.This was verified with the caller phonetically.A sample of the product was available to be returned, if requested.The action taken for the product and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Site sample has not been received.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.

Event Description

Event verbatim [preferred term] 1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side [device breakage], , narrative: the initial case was missing the following minimum criteria: [no adverse effect].Upon receipt of follow-up information on [14dec2020], this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date jun2023, upc number: (b)(4),via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated he found on (b)(6)2020 both wraps were rock hard.He put one of them on his neck, but it didn't heat up, so he didn't even try the other one.The 3rd wrap in the box was soft, so he used that one and it worked.The reporter stated that the corner of packaging was kind of funky.Clarified that 1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side.Agent provided lot number as bt2269, but caller stated that it was ec2269.This was verified with the caller phonetically.A sample of the product was available to be returned, if requested.The action taken for the product and event outcome was unknown.According to product quality group: complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Site sample has not been received.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow-up (24dec2020): follow-up attempts are completed.No further information is expected.Follow-up (15jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Event Description

Event verbatim [preferred term] 1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side [device breakage], , narrative: the initial case was missing the following minimum criteria: [no adverse effect].Upon receipt of follow-up information on [14dec2020], this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date jun2023, upc number: (b)(6) ,via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated he found on (b)(6) 2020 both wraps were rock hard.He put one of them on his neck, but it didn't heat up, so he didn't even try the other one.The 3rd wrap in the box was soft, so he used that one and it worked.The reporter stated that the corner of packaging was kind of funky.Clarified that 1 wrapper had a hole in it, and the other one looked like it was melted where the end was cut on the bottom right side.Agent provided lot number as bt2269, but caller stated that it was ec2269.This was verified with the caller phonetically.A sample of the product was available to be returned, if requested.The action taken for the product and event outcome was unknown.According to product quality group: complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Site sample has not been received.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Additional information received from product quality group: complaint sub-class: primary container damage/defect not classified.Site sample has not been received.The root cause for never worked, too cool, did not last enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal complete (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal wrapper machines in bath production lines.The severity of pouch leaks is s1 no harm to customer.Follow-up (24dec2020): follow-up attempts are completed.No further information is expected.Follow-up (15jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (25jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Site sample has not been received.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Additional information received from product quality group: complaint sub-class: primary container damage/defect not classified.Site sample has not been received.The root cause for never worked, too cool, did not last enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal complete (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal wrapper machines in bath production lines.The severity of pouch leaks is s1 no harm to customer.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11065908
• MDR Text Key: 239269512
• Report Number: 1066015-2020-00206
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 305733015025
• 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: 12/14/2020

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
• Device Expiration Date: 06/01/2023
• Device Lot Number: EC2269
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2021; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1