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

Device Problem Leak/Splash (1354)

Patient Problem Caustic/Chemical Burns (2549)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number menstrual 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 product quality related trend identified for the subclass adverse event safety request for investigation.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.Based on the complaint narrative, the patient sustained a burn injury due to leakage with product use.Review of complaint description concludes there is a device malfunction.Severity of harm: s3.

Event Description

Event verbatim [preferred term] chemical burn on my stomach [chemical burn of skin] , device leakage [device leakage] ,.Case narrative: this is a spontaneous report from a pfizer sponsored program thermacare power reviews.A contactable consumer (patient) reported the patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date at an unspecified frequency for cramps.The patient medical history and concomitant medications were not reported.The patient stated, "thermacare menstrual pain therapy great for cramps but chemically burned my skin.I rather use the pads than to take medicine.The last time i used the heating pad it gave me a chemical burn on my stomach".The action taken in response to the event was unknown.The event outcome was unknown.Per the product quality group, this investigation was conducted for an unknown lot number menstrual 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 product quality related trend identified for the subclass adverse event safety request for investigation.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.Based on the complaint narrative, the patient sustained a burn injury due to leakage with product use.Review of complaint description concludes there is a device malfunction.Severity of harm: s3.Follow-up (02jul2019): follow-up attempts are completed.No further information is expected.Follow-up (25sep2019): new information received from the product quality complaint (pqc) group includes: investigation summary.Follow-up (22oct2019): new information received from the pqc group includes: severity of harm rating (s3).Follow-up (22apr2018): new information received from the pqc group includes: reaction data (new event of device leakage).This is a follow-up is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment based on the information provided, the events of "chemical burn" and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Device leakage is a single potential device malfunction, which has a theoretical risk to cause skin burn.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.This case will be re-assessed should additional information become available., comment: based on the information provided, the events of "chemical burn" and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Device leakage is a single potential device malfunction, which has a theoretical risk to cause skin burn.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.This case will be re-assessed should additional information become available.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9354438
• MDR Text Key: 185886340
• Report Number: 1066015-2019-00484
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention