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

Lot Number N15262

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Pfizer (b)(4) investigational report conclusion: the most probable root cause of this event is in the equipment category, mechanical failure.The die cutter incoming conveyor most probably slipped on the drive roll causing the web to stall or stretch.This resulted in the material in the die cutter either pulling back up stream as the leading edge was cut or stretching as it was being pulled into the die cutter rather than being driven into the die under a controlled manner.Additionally, the nip roll transitioning the web from the folding section to the die cutter infeed conveyor was worn and not driving the web which would have helped to ease the web drag if the infeed conveyor slips on the drive roll.Batch n15262 is within the final scope of this investigation and remains in released status.

Event Description

Event verbatim [preferred term] one heat wrap of a 4ct pack had damaged heat cells where the content leaked.The defect was noticed before use.[device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number n15262, expiration date feb2019, via an unspecified route of administration, from an unspecified date to an unspecified date, for an unspecified indication.The patient 's medical history and concomitant medications were not reported.The pharmacist reported "one heat wrap of a 4 ct.Pack had damaged heat cells where the content leaked.The defect was noticed before use" on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.The pfizer investigational report received on 19jan2017 for thermacare heatwrap concluded: the most probable root cause of this event is in the equipment category, mechanical failure.The die cutter incoming conveyor most probably slipped on the drive roll causing the web to stall or stretch.This resulted in the material in the die cutter either pulling back up stream as the leading edge was cut or stretching as it was being pulled into the die cutter rather than being driven into the die under a controlled manner.Additionally, the nip roll transitioning the web from the folding section to the die cutter infeed conveyor was worn and not driving the web which would have helped to ease the web drag if the infeed conveyor slips on the drive roll.Batch n15262 is within the final scope of this investigation and remains in released status.No follow-up attempts are needed.No further information is expected.Company clinical evaluation comment the event "one heat wrap of a 4 ct.Pack had damaged heat cells where the content leaked" (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 "one heat wrap of a 4 ct.Pack had damaged heat cells where the content leaked" (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

Pfizer albany investigational report conclusion: the most probable root cause of this event is in the equipment category, mechanical failure.The die cutter incoming conveyor most probably slipped on the drive roll causing the web to stall or stretch.This resulted in the material in the die cutter either pulling back up stream as the leading edge was cut or stretching as it was being pulled into the die cutter rather than being driven into the die under a controlled manner.Additionally, the nip roll transitioning the web from the folding section to the die cutter infeed conveyor was worn and not driving the web which would have helped to ease the web drag if the infeed conveyor slips on the drive roll.Batch n15262 is within the final scope of this investigation and remains in released status.

Event Description

Event verbatim [preferred term] one heat wrap of a 4ct pack had damaged heat cells where the content leaked.The defect was noticed before use.[device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number n15262, expiration date feb2019, via an unspecified route of administration, from an unspecified date to an unspecified date, for an unspecified indication.The patient 's medical history and concomitant medications were not reported.The pharmacist reported "one heat wrap of a 4 ct.Pack had damaged heat cells where the content leaked.The defect was noticed before use" on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.The pfizer investigational report received on 19jan2017 for thermacare heatwrap concluded: the most probable root cause of this event is in the equipment category, mechanical failure.The die cutter incoming conveyor most probably slipped on the drive roll causing the web to stall or stretch.This resulted in the material in the die cutter either pulling back up stream as the leading edge was cut or stretching as it was being pulled into the die cutter rather than being driven into the die under a controlled manner.Additionally, the nip roll transitioning the web from the folding section to the die cutter infeed conveyor was worn and not driving the web which would have helped to ease the web drag if the infeed conveyor slips on the drive roll.Batch n15262 is within the final scope of this investigation and remains in released status.No follow-up attempts are needed.No further information is expected.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: the event "one heat wrap of a 4 ct.Pack had damaged heat cells where the content leaked" (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.The most probable root cause of this event is in the equipment category, mechanical failure.Batch n15262 is within the final scope of this investigation and remains in released status.

• 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: 9263326
• MDR Text Key: 220271986
• Report Number: 1066015-2019-00450
• 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
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Lot Number: N15262
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1