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

Lot Number T78907

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

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Respiratory Distress (2045)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Complaint is an adverse event.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Design related: no.Complaint confirmed: no.Notify safety: no.

Event Description

Problems breathing [respiratory disorder], stomach distress/stomach problems [abdominal discomfort].Case narrative: this is spontaneous report from a contactable consumer reported for her husband.A male patient of unknown age started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot#: t78907, expiration date: nov2020, on (b)(6) 2018 at unknown frequency for an unknown indication.The patient medical history and concomitant medications were not reported.The patient used thermacare multi-purpose heatwrap, had a reaction.He had problems with his stomach.It caused him stomach distress and problems breathing on (b)(6) 2018.Within an hour his breathing returned to normal and stomach issues were still on-going.The reporter stated that it was not anaphylactic shock or anything, and wanted to know what was in the wraps.The patient didn't come in contact with it again.She couldn't see on the label what was in the wraps.The action taken in response to the events of the product was permanently withdrawn.The outcome of stomach distress/stomach problems was not resolved.The outcome of problems breathing was resolved on (b)(6) 2018.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Complaint is an adverse event.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Design related: no.Complaint confirmed: no.Notify safety: no.Additional information has been requested and will be provided as it becomes available.Follow-up (21jun2018): this is a follow-up report combining information from duplicate reports (b)(4) and (b)(4).The current and all subsequent information will be reported under manufacturer report number (b)(4).The new information reported from a contactable consumer includes additional reporter, device data (trade name updated, start date and stop date) and event details.Follow-up attempts are completed.No further information is expected.Follow-up (23jul2018): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (11jun2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events of "stomach distress and problems breathing " as described are considered serious medical conditions potentially requiring medical intervention to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.Comment: based on the information provided, the events of "stomach distress and problems breathing " as described are considered serious medical conditions potentially requiring medical intervention to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• 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: 9260324
• MDR Text Key: 185761691
• Report Number: 1066015-2019-00422
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2018

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
• Device Expiration Date: 11/01/2020
• Device Lot Number: T78907
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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