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

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Swelling (2091); Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn/ blistered up/ really red/ sore [burns second degree], one of the blisters that popped/ started bleeding [blister rupture], one of the blisters that popped/ started bleeding [haemorrhage], use for endometriosis [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and race/ethnicity started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for cramps and endometriosis.Relevant medical history and concomitant medications were not reported.The patient reported using this heatwrap "last week" in (b)(6) 2017 and after about 5 to 6 hours, she took it off.She found that the area where the heatwrap was applied was really red and "it burned me pretty badly." the next day, it had blistered up on the right side and then had another one pop up on the left side.The patient has had the burn a week, feels sore all the time and it still looks bad.Therapeutic measures included applying neosporin and band aids on it [blisters] but it started bleeding "last night".It finally is starting to heal a little bit on one of the blisters that popped.The patient stated she has not seen her doctor yet.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event one of the blisters that popped is recovering.The outcome of other events is 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 burns second degree, blister rupture and blister bleeding as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device use issue is non-serious and assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree, blister rupture and blister bleeding as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device use issue is non-serious and assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Burn/ blistered up/ really red/ sore [burns second degree], one of the blisters that popped/ started bleeding [blister rupture], one of the blisters that popped/ started bleeding [haemorrhage], use for endometriosis [device use issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for cramps and endometriosis.Relevant medical history and concomitant medications were not reported.The patient reported using this heatwrap "last week" in (b)(6) 2017 and after about 5 to 6 hours she took it off.She found that the area where the heatwrap was applied was really red and "it burned me pretty badly." the next day it had blistered up on the right side and then had another one pop up on the left side.The patient has had the burn a week, feels sore all the time and it still looks bad.Therapeutic measures included applying neosporin and band aids on it [blisters] but it started bleeding "last night".It finally is starting to heal a little bit on one of the blisters that popped.The patient stated she has not seen her doctor yet.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event one of the blisters that popped is recovering.The outcome of other events is unknown.According to product quality complaint group: site had not received sample.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.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 safety request for investigation.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 assmt.& rationale: a lot trend was not performed.The lot number is unknown.Follow-up (12apr2017): follow-up attempts are completed.No further information is expected.Follow-up (16apr2020): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of burns second degree, blister rupture and blister bleeding as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device use issue is non-serious and 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 further investigations or actions is suggested at this time.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 trend identified related for the subclass adverse event safety request for investigation.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 safety request for investigation.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 assmt.& rationale: a lot trend was not performed.The lot number is unknown.

• 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: 6350384
• MDR Text Key: 68084530
• Report Number: 1066015-2017-00038
• 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: 02/12/2017

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention