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

Lot Number S91704

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

Sample evaluation: one wrap - wrap shows evidence of wear.One cell pack has excess brine outside of one of the cells.One pouch - s91704 s 07/07, expiration date: jun-2020, pouch is open - no obvious defects.Severity rank: s3.Device malfunction confirmed per (b)(4) bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective (b)(6) 2018, version 1.0.# 1.1.1.1 potential hazard ¿ skin burn, severity rank s3.

Event Description

Event verbatim [preferred term] the warming element had reacted too intense, it was too hot and very dark [device issue].Case narrative:the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on (b)(6) 2018, this case now contains all required information to be considered valid.This is a spontaneous report from a non-contactable consumer or other non hcp.A female patient of unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number s91704, expiration date jun2020) from an unspecified date for problems with her muscles.The patient's medical history and concomitant medications were not reported.On (b)(6) 2018, the patient reported the heatwraps did not have the usual quality.Upon opening the first package, the heatwrap was already hard, had already reacted and therefore didn't get warm any more.On (b)(6) 2018, the patient opened a second package and applied it on herself.Only a few minutes later, her husband looked at the heatwrap and found out that the warming element had reacted too intense, it was too hot and very dark.So, she stopped using it.She stated 2 out of 6 heatwraps didn't work.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: one wrap - wrap shows evidence of wear.One cell pack has excess brine outside of one of the cells.One pouch - s91704 s 07/07, expiration date: jun2020, pouch is open - no obvious defects.Severity rank: s3.Device malfunction confirmed per (b)(4) bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective (b)(6) 2018, version 1.0.# 1.1.1.1 potential hazard - skin burn, severity rank s3.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the device malfunction from the returned sample has been confirmed.The patient followed the instruction and stopped the use upon identification of the device issue "warming element had reacted too intense, it was too hot and very dark".No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the device malfunction from the returned sample has been confirmed.The patient followed the instruction and stopped the use upon identification of the device issue "warming element had reacted too intense, it was too hot and very dark".No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

Sample evaluation: one wrap - wrap shows evidence of wear.One cell pack has excess brine outside of one of the cells.One pouch - s91704 s 07/07, expiration date: jun-2020, pouch is open - no obvious defects.Severity rank: s3.Device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28-sep-2018, version 1.0.# 1.1.1.1 potential hazard ¿ skin burn, severity rank s3.Upon follow-up, product quality complaints group provided the following investigation report: pfizer (city) investigational report for lot: s91704: the most probable root cause for this event was classified under equipment / mechanical failure.The brine solution is susceptible to create salt deposits in the brine pump system.The most probable root cause of this incident was a partially clogged brine nozzle.The returned wrap shows brine solution dispensed outside the cell (edge of the wrap).This event could occur when the brine solution normal flow is deviated by a clog in the brine nozzle.The brine outside the cell flowed to cell surroundings affecting the sealing.The brine solution path created an unseal channel (delamination) that could allow chemistry leaking.In addition, the cell pack delamination may allow more air coming through the cell causing an increase of the cell temperature (hot cell).Since the wrap delamination was minor there was no significant leakage of chemistry out of the cell.When this batch was manufactured, there was not preventive maintenance (pm) in place to inspect and cleaning the pumps, lines and nozzles routinely.Commitment (b)(4) was completed on 18 june 2018 (after batch s91704 manufacturing) to implement the preventive maintenance (pm) for the brine pumps on both line (b & m).The pm includes the nozzle cleaning in a monthly basis.In addition, the following capas were implemented to prevent brine outside cell issues: (b)(4): create an mwi for purging brine (completed on 28 sep 2018).

Event Description

The warming element had reacted too intense, it was too hot and very dark [device issue].Case narrative: the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on 26nov2018, this case now contains all required information to be considered valid.This is a spontaneous report from a non-contactable consumer or other non hcp.A female patient of unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: s91704, expiration date: jun2020) from an unspecified date for problems with her muscles.The patient's medical history and concomitant medications were not reported.On (b)(6) 2018, the patient reported the heatwraps did not have the usual quality.Upon opening the first package, the heatwrap was already hard, had already reacted and therefore didn't get warm any more.On (b)(6) 2018, the patient opened a second package and applied it on herself.Only a few minutes later, her husband looked at the heatwrap and found out that the warming element had reacted too intense, it was too hot and very dark.So, she stopped using it.She stated 2 out of 6 heatwraps didn't work.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: one wrap - wrap shows evidence of wear.One cell pack has excess brine outside of one of the cells.One pouch - s91704 s 07/07, expiration date: jun2020, pouch is open - no obvious defects.Severity rank: s3.Device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0.# 1.1.1.1 potential hazard - skin burn, severity rank s3.Upon follow-up, product quality complaints group provided the following investigation report: pfizer (city) investigational report for lot s91704: the most probable root cause for this event was classified under equipment / mechanical failure.The brine solution is susceptible to create salt deposits in the brine pump system.The most probable root cause of this incident was a partially clogged brine nozzle.The returned wrap shows brine solution dispensed outside the cell (edge of the wrap).This event could occur when the brine solution normal flow is deviated by a clog in the brine nozzle.The brine outside the cell flowed to cell surroundings affecting the sealing.The brine solution path created an unseal channel (delamination) that could allow chemistry leaking.In addition, the cell pack delamination may allow more air coming through the cell causing an increase of the cell temperature (hot cell).Since the wrap delamination was minor there was no significant leakage of chemistry out of the cell.When this batch was manufactured, there was not preventive maintenance (pm) in place to inspect and cleaning the pumps, lines and nozzles routinely.Commitment (b)(4) was completed on 18 june 2018 (after batch: s91704 manufacturing) to implement the preventive maintenance (pm) for the brine pumps on both line (b & m).The pm includes the nozzle cleaning in a monthly basis.In addition, the following capas were implemented to prevent brine outside cell issues: (b)(4): create an mwi for purging brine (completed on 28 sep 2018), (b)(4): pa 2: replace current brine manifold to dispensing plate supply lines (push/pull quick disconnect) with a line with a permanent (screw on) connector design (completed on 02 oct 2018), (b)(4): implement hpm hourly inspection (completed on 31 oct 2018).No further action is recommended for batch s91704, this is the first complaint for batch: s91704 related to the brine outside of the cell preventing sealing the cell pack films.Batch s91704 remains in release status.Follow-up (23feb2019): new information from product quality complaints includes: additional quality investigation results.Company clinical evaluation comment: the device malfunction from the returned sample has been confirmed.The patient followed the instruction and stopped the use upon identification of the device issue "warming element had reacted too intense, it was too hot and very dark".No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company conducted an investigation, and the most probable root cause for this event was classified, capas were implemented, and no further action is recommended for batch s91704., comment: the device malfunction from the returned sample has been confirmed.The patient followed the instruction and stopped the use upon identification of the device issue "warming element had reacted too intense, it was too hot and very dark".No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company conducted an investigation, and the most probable root cause for this event was classified, capas were implemented, and no further action is recommended for batch: s91704.

• 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: 8191699
• MDR Text Key: 132378489
• Report Number: 1066015-2018-00202
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Lot Number: S91704
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1