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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Type  Injury  

Event Description

Deep chemical burn in one spot [chemical burn of skin].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare menstrual) 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 "i've gotten what seems to be a deep chemical burn in one spot, after using this wrap for less than an hour.No problems with previous uses." the patient stated she was worried about any chemical residue or an interaction with any topical treatments.Action taken with the suspect product was unknown.Clinical outcome of the event 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 chemical burn of skin as described in this case is considered a 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.This case meets initial 10-day (b)(4) and 30-day fda reportability.

Manufacturer Narrative

Site sample status was not received.Root cause /capa: process related was no.Final confirmation status was not confirmed.This investigation was conducted for an unknown lot number menstrual 8hr product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed.The lot number is unknown.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.

Event Description

Event verbatim [preferred term].Deep chemical burn in one spot [chemical burn of skin].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) 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 she'd gotten what seemed to be a deep chemical burn in one spot, after using this wrap for less than an hour.No problems with previous uses.The patient stated she was worried about any chemical residue or an interaction with any topical treatments.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to the product quality complaint group, site sample status was not received.Root cause /capa: process related was no.Final confirmation status was not confirmed.This investigation was conducted for an unknown lot number menstrual 8hr product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed.The lot number is unknown.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.Follow-up (14jan2016): follow-up attempts completed.No further information expected.Follow-up (13aug2020): new information received from the product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

• 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: 5314156
• MDR Text Key: 33998827
• Report Number: 1066015-2015-00158
• 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: 11/21/2015

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: 11/21/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: 11/21/2015
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention