MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number S91709

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Gave me blisters/burning myself [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number s91709, expiration date jun2020, from an unspecified date at an unknown dose for pain management.The patient medical history and concomitant medications were not reported.The patient stated that she 13-20 currently of the advanced joint pain therapy that's supposed to work for 8 hours.The info from the back on the packaging as: l s91709 n jul2011 exp: jun2020 18:11.The patient reported that the last one she used gave her blisters on an unspecified date.She had been using these for years for pain management and the batch she currently had seemed to be unregulated in the amount of the heating ingredient or something.Because after burning herself, months later she'd tried to use multiple of the packs and they did not heat up at all.They were worthless and she had spent lots of these.The patient had them stashed throughout her house so she was not sure how many beyond the 13-15 she had currently.But she would love to get these faulty ones replaced, as she woke up at 4 am today ((b)(6) 2019) needing relief and they weren't heating up, which means she was in pain now for hours until stores open.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following:released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1 - no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.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] gave her blisters/burning herself [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number s91709, expiration date jun2020) from an unspecified date for pain management.The patient's medical history and concomitant medications were not reported.The patient stated that she currently has 13-20 of the advanced joint pain therapy that's supposed to work for 8 hours.The information from the back on the packaging as: l s91709 n jul2011 exp: jun2020 18:11.The patient reported that the last one she used gave her blisters on an unspecified date.She had been using these for years for pain management and the batch she currently had seemed to be unregulated in the amount of the heating ingredient or something.Because after burning herself, months later she'd tried to use multiple of the packs and they did not heat up at all.They were worthless, and she had spent lots of these.The patient had them stashed throughout her house, so she was not sure how many beyond the 13-15 she had currently.But she would love to get these faulty ones replaced, as she woke up at 4 am today (27jul2019) needing relief and they weren't heating up, which meant she was in pain now for hours until stores open.Action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following:released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1 - no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.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 has been requested and will be provided as it becomes available.Follow-up (26sep2019): follow-up attempts are completed.No further information is expected.Follow-up (04sep2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8893494
• MDR Text Key: 155220844
• Report Number: 1066015-2019-00213
• 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
• Type of Report: Initial,Followup
• Report Date: 07/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Lot Number: S91709
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention