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

Lot Number R67987

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

Sub class: cells damaged/leaking.The most probable root cause of this event is method/document doesn't exist.Equipment is a contributory root cause.This incident could be occurred by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation.The excessive wear in the cell pack cut out area of the nip roll that allowed the web to slip before the die cutter conveyor is a contributory factor.If the web is not well controlled (slipping) the registration optics will be triggered erratically and the web cut position will become inconsistent.This caused the die popping continuously and the manufacturing technician had to perform more troubleshooting and die re-adjustment to keep the line running.This increase the probability to produce cut cell wraps during the troubleshooting process.No market action was recommended because the chemistry leakage is visual upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Therefore, this investigation recommends no further actions to be taken for batch r67987.

Event Description

Wrap was split with charcoal all over [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number r67987, expiration date aug2019, udi number (b)(4), from an unspecified date at unknown frequency for back issues.The patient medical history and concomitant medications were not reported.The patient had had back issues and she had been buying these wraps for about 5 years.She bought a box with 2 plus 1 free wrap.When she opened the box, the wrap was split with the charcoal all over.She clarified there was charcoal in the pouch that she found when she went to pull the wrap out.It was split across the top and black stuff was everywhere.The second wrap was the same way.She did not open the third wrap, but she shook the pouch and she could tell it was the same way.Device was available for evaluation.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sub class: cells damaged/leaking.The most probable root cause of this event is method/document doesn't exist.Equipment is a contributory root cause.This incident could be occurred by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation.The excessive wear in the cell pack cut out area of the nip roll that allowed the web to slip before the die cutter conveyor is a contributory factor.If the web is not well controlled (slipping) the registration optics will be triggered erratically and the web cut position will become inconsistent.This caused the die popping continuously and the manufacturing technician had to perform more troubleshooting and die re-adjustment to keep the line running.This increase the probability to produce cut cell wraps during the troubleshooting process.No market action was recommended because the chemistry leakage is visual upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Therefore, this investigation recommends no further actions to be taken for batch r67987.No follow up attempts are needed.No further information is expected.Follow-up (b)(6) 2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the event "wrap was split with charcoal all over" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "wrap was split with charcoal all over" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

Sub class: cells damaged/leaking.The most probable root cause of this event is method/document doesn't exist.Equipment is a contributory root cause.This incident could be occurred by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation.The excessive wear in the cell pack cut out area of the nip roll that allowed the web to slip before the die cutter conveyor is a contributory factor.If the web is not well controlled (slipping) the registration optics will be triggered erratically and the web cut position will become inconsistent.This caused the die popping continuously and the manufacturing technician had to perform more troubleshooting and die re-adjustment to keep the line running.This increase the probability to produce cut cell wraps during the troubleshooting process.No market action was recommended because the chemistry leakage is visual upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Therefore, this investigation recommends no further actions to be taken for batch r67987.

Event Description

Event verbatim [preferred term] wrap was split with charcoal all over/all 3 had a split on top [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A 59-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number r67987, expiration date aug2019, udi number (b)(4), from an unspecified date at unknown frequency for back issues.The patient medical history and concomitant medications were not reported.The patient had back issues and she had been buying these wraps for about 5 years.She bought a box with 2 plus 1 free wrap.When she opened the box, the wrap was split with the charcoal all over.She clarified there was charcoal in the pouch that she found when she went to pull the wrap out.It was split across the top and black stuff was everywhere.The second wrap was the same way.She did not open the third wrap, but she shook the pouch and she could tell it was the same way.Device was available for evaluation.The patient had purchased thermacare bonus 3pk.All 3 had a split on top.Probably happened in manufacturing process.She didn't use them.She had been using thermacare heatwraps for over 8 yrs and never had any problems.One time incident.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sub class: cells damaged/leaking.The most probable root cause of this event is method/document doesn't exist.Equipment is a contributory root cause.This incident could be occurred by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation.The excessive wear in the cell pack cut out area of the nip roll that allowed the web to slip before the die cutter conveyor is a contributory factor.If the web is not well controlled (slipping) the registration optics will be triggered erratically and the web cut position will become inconsistent.This caused the die popping continuously and the manufacturing technician had to perform more troubleshooting and die re-adjustment to keep the line running.This increase the probability to produce cut cell wraps during the troubleshooting process.No market action was recommended because the chemistry leakage is visual upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Therefore, this investigation recommends no further actions to be taken for batch r67987.No follow up attempts are needed.No further information is expected.Follow-up (09may2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up(12nov2019): new information received from a contactable consumer included: patient data (age, weight), past product history.Company clinical evaluation comment: the event "wrap was split with charcoal all over" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.No remedial action/corrective action/field safety corrective action is suggested at this time, comment: the event "wrap was split with charcoal all over" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 9257599
• MDR Text Key: 189095427
• Report Number: 1066015-2019-00320
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010075
• UDI-Public: 305733010075
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Lot Number: R67987
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 54