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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Very painful burn blister/little stinging and sore/the blister was still there, red and inflamed and extremely sore to the touch [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare menstrual) on an unknown date for cramps.Relevant medical history and concomitant medications were not provided.The patient was beyond upset with his/her experience with the product.The patient used the product for cramps and after wearing it for three hours, he/she noticed a little stinging and sore so he/she took the patch off.By the next morning, a very painful burn blister had formed.Days later, the blister was still there, red and inflamed and extremely sore to the touch.The patient was appalled that this product caused him/her an actual burn, a product that he/she paid for to help and a product that he/she had only been wearing for three hours.That was the first patch he/she used.Not only the patient was out of money, but he/she was dealing with a burn that had still not gone away.The patient was very upset about this situation.He/she hoped this did not happen to anyone else.The patient would never be buying this product again and would also be discouraging friends from doing so.Thermacare heatwrap was permanently withdrawn in response to the event.The patient had not recovered from the event at the time of the report.Additional information has been requested and will be provided as it becomes available.Comment: based on the information provided, the event burn blister 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.

Event Description

Event verbatim [preferred term] very painful burn blister/little stinging and sore/the blister was still there, red and inflamed and extremely sore to the touch [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare menstrual) on an unknown date for cramps.Relevant medical history and concomitant medications were not provided.The patient was beyond upset with his/her experience with the product.The patient used the product for cramps and after wearing it for three hours, he/she noticed a little stinging and sore so he/she took the patch off.By the next morning, a very painful burn blister had formed.Days later, the blister was still there, red and inflamed and extremely sore to the touch.The patient was appalled that this product caused him/her an actual burn, a product that he/she paid for to help and a product that he/she had only been wearing for three hours.That was the first patch he/she used.Not only the patient was out of money, but he/she was dealing with a burn that had still not gone away.The patient was very upset about this situation.He/she hoped this did not happen to anyone else.The patient would never be buying this product again and would also be discouraging friends from doing so.Thermacare heatwrap was permanently withdrawn in response to the event.The patient had not recovered from the event at the time of the report.According to product quality complaints group, this investigation was conducted for an unknown lot number menstrual 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown the manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.There was reasonably suggest device malfunction.Severity of harm was s3.Follow-up (08apr2020): new information received from a product quality complaints group included: investigation result., comment: based on the information provided, the event burn blister 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown the manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

• 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: 9813570
• MDR Text Key: 189322784
• Report Number: 1066015-2020-00063
• 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: 02/21/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention