MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Lot Number T26691

Device Problems Leak/Splash (1354); Nonstandard Device (1420); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.The root cause category is equipment/other with method as a contributory factor.This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Our manufacturing operations employ quality control procedures which include in process 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.This batch has been reviewed from a manufacturing perspective.There are no known investigations for this batch at the time of release.Investigation pr # t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26691 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516).

Event Description

There was a hole in the wrap so the granules spilled out [device leakage].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number t26691, expiration date jul2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported there was a hole in the wrap so the granules spilled out.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.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.The root cause category is equipment/other with method as a contributory factor.This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Our manufacturing operations employ quality control procedures which include in process 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.This batch has been reviewed from a manufacturing perspective.There are no known investigations for this batch at the time of release.Investigation pr # t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26691 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516).Company clinical evaluation comment: the above referenced lot number t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.

Event Description

There was a hole in the wrap so the granules spilled out [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A 49-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: t26691, expiration date: jul2020) from an unspecified date and ongoing at 1 heat pad per day for menstrual cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported there was a hole in the wrap so the granules spilled out.No admission to hospital involved.No treatment received.Action taken with the suspect product was unknown.Clinical outcome of the event was resolved.According to the product quality complaint group: this is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Subclass: battery cells damaged/leaking.Sample status: photos attached.Further investigation req'd: no.Investigation summary: the root cause for this investigation was revised per investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking.And to complete action item: (b)(4): identify & update all previous complaint investigations due to unsealed cells for the four batches.The market action was also added.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.This created a scenario where a small amount of air could enter the supply line and this air discharged as the line ran at the slower steady state of the slower variable speed of 100 wraps per minute (wpm); then, the brine sputtered as the air bubble discharged from the brine nozzle, placing the brine outside of the cell area.Because the brine is injected slightly forward during slower speeds, this brine outside of the cell rolled upstream due to the motion of the platens as they travel forward in the machine direction.This liquid (brine) traveled upstream, covering the surface of the bottom film and the dosed pre mix powder for multiple cells of the wrap.This brine outside of the cell was captured between the hpm films preventing the top and bottom film layers from being bonded by the seal roll.Due to the perimeter of the cell area not being bonded (layer of two films), it allowed the pre-mix powder to flow outside of the cell area.Our manufacturing operations employ quality control procedures which include in process 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.This batch has been reviewed from a manufacturing perspective.There are no known investigations for this batch at the time of release.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch: t26691 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Notification to safety in response to the 483 observation 3 was sent on 09apr-2019.Process related: yes.Complaint confirmed: no.Final confirmation status: confirmed, capas known.Follow-up (17apr2019): new information received from the product quality complaint group includes investigational results.Follow-up (17may2019): new information received from a contactable consumer includes patient data (age), device data (indication, dose, frequency), outcome of event, deny of hospitalization and deny of treatment.Company clinical evaluation comment: the above referenced lot number: t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number: t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.

Manufacturer Narrative

This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Subclass: battery cells damaged/leaking.Sample status: photos attached.Further investigation req'd: no.Investigation summary: the root cause for this investigation was revised per investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking.And to complete action item: (b)(4): identify & update all previous complaint investigations due to unsealed cells for the four batches.The market action was also added.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.This created a scenario where a small amount of air could enter the supply line and this air discharged as the line ran at the slower steady state of the slower variable speed of 100 wraps per minute (wpm); then, the brine sputtered as the air bubble discharged from the brine nozzle, placing the brine outside of the cell area.Because the brine is injected slightly forward during slower speeds, this brine outside of the cell rolled upstream due to the motion of the platens as they travel forward in the machine direction.This liquid (brine) traveled upstream, covering the surf.

Event Description

There was a hole in the wrap so the granules spilled out [device leakage].Case narrative: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number: t26691, expiration date: jul2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported there was a hole in the wrap so the granules spilled out.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to the product quality complaint group: this is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Subclass: battery cells damaged/leaking.Sample status: photos attached.Further investigation req'd: no.Investigation summary: the root cause for this investigation was revised per investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking.And to complete action item (b)(4): identify & update all previous complaint investigations due to unsealed cells for the four batches.The market action was also added.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.This created a scenario where a small amount of air could enter the supply line and this air discharged as the line ran at the slower steady state of the slower variable speed of 100 wraps per minute (wpm); then, the brine sputtered as the air bubble discharged from the brine nozzle, placing the brine outside of the cell area.Because the brine is injected slightly forward during slower speeds, this brine outside of the cell rolled upstream due to the motion of the platens as they travel forward in the machine direction.This liquid (brine) traveled upstream, covering the surface of the bottom film and the dosed pre mix powder for multiple cells of the wrap.This brine outside of the cell was captured between the hpm films preventing the top and bottom film layers from being bonded by the seal roll.Due to the perimeter of the cell area not being bonded (layer of two films), it allowed the pre-mix powder to flow outside of the cell area.Our manufacturing operations employ quality control procedures which include in process 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.This batch has been reviewed from a manufacturing perspective.There are no known investigations for this batch at the time of release.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26691 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Notification to safety in response to the 483 observation 3 was sent on 09apr-2019.Process related: yes.Complaint confirmed: no.Final confirmation status: confirmed - capas known.Follow-up (17apr2019): new information received from the product quality complaint group includes investigational results.Company clinical evaluation comment: the above referenced lot number: t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number: t26691 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.

Manufacturer Narrative

This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp.A device malfunction of cell pack damage/leaking was confirmed.Return sample evaluation: one menstrual wrap - wrap does not show evidence of wear.Two cell packs are leaking chemistry out the side of the wrap.Subclass: battery cells damaged/leaking.Sample status: photos attached.Further investigation req'd: no.Investigation summary: the root cause for this investigation was revised per investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking.And to complete action item (b)(4): identify & update all previous complaint investigations due to unsealed cells for the four batches.The market action was also added.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.This created a scenario where a small amount of air could enter the supply line and this air discharged as the line ran at the slower steady state of the slower variable speed of 100 wraps per minute (wpm); then, the brine sputtered as the air bubble discharged from the brine nozzle, placing the brine outside of the cell area.Because the brine is injected slightly forward during slower speeds, this brine outside of the cell rolled upstream due to the motion of the platens as they travel forward in the machine direction.This liquid (brine) traveled upstream, covering the surf.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8516703
• MDR Text Key: 160444688
• Report Number: 1066015-2019-00108
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Lot Number: T26691
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR