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

Lot Number T26686

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

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.Consumer reports she ¿got a blister¿ from a wrap she wore.The cause of the blister 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.This batch t26686 was involved in investigation pr-2379610-t26691, t26693, t26686 & s68516 menstrual & muscle joint us- cells damaged/leaking.The batch was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr-2379610 for cell pack damage/leaking.This current complaint does not involve cell damage/leaking.Process related: no; complaint confirmed: no.

Event Description

Event verbatim [preferred term] blisters [blister] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number t26686, expiration date jul2020, udi number: (b)(4).Since an unspecified date (too many years ago, it had been 5 or 6 years ago) at unknown frequency for muscle pain, shoulder pain, and elbow pain.Medical history included torn rotator cuff from an unknown date and unknown if ongoing and shrunk two and a half inches (when the patient was (b)(6) she was 5 foot 11 and now she was (b)(6) and she was 5 foot seven and a half).There were no concomitant medications.The patient stated, she had a box of the thermacare she got a letter from the (club name) where she bought it, it was on a recall.The patient mentioned no doctor prescribed it to her.She used it ((thermacare heatwraps multi-purpose muscle pain) before until she got to a doctor.The patient stated, she had a torn rotator cuff, she had elbow that needed to be replace it was bone on bone, she had pain.That was why she used these (thermacare heatwraps multi-purpose muscle pain).The patient further stated, "it's bone on bone it needs replaced.I don't want to do it right now.My orthopedic doctor gives me injection in it every so often just like he gives me injections in my shoulder." the patient experienced blisters on (b)(6) 2018.The patient stated that she didn't have that box, she got a blister from.She threw the thing away that was after she threw it away she discovered she had the blister, and then yesterday ((b)(6) 2018) she got the letter and today ((b)(6) 2018) she looked at her packages and she still had one at the package with a batch number on it.But she had the unopened one (recalled box).The patient stated, she hadn't looked at it yet since, it was still there, it hadn't burst yet this morning (on (b)(6) 2018).The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not resolved.As of (b)(6) 2018, the product quality complaint (pqc) group investigation results stated that 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.Consumer reports she 'got a blister' from a wrap she wore.The cause of the blister 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.This batch t26686 was involved in investigation pr-2379610-t26691, t26693, t26686 & s68516 menstrual & muscle joint us- cells damaged/leaking.The batch was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr-2379610 for cell pack damage/leaking.This current complaint does not involve cell damage/leaking.Process related: no; complaint confirmed: no.No follow-up attempts are possible.No further information is expected.Follow-up ((b)(6) 2018): new information reported from the pqc group includes: product investigation summary results.No follow-up attempts are possible.No further information is expected.Follow-up ((b)(6) 2018): 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 event blisters 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., comment: based on the information provided, the event blisters 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.

Manufacturer Narrative

Batch t26686 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the three pouched wraps inside.Inspection shows no obvious defects to the cartons or pouched wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 07nov2018.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint of adverse event.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per (b)(4); effective date: 04aug2017.Shiftly production transition notes were reviewed.There were no issues noted in the heat pack maker portion of the line that would have caused cells to be damaged or leaking or affect the wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.One previous complaint (#-us, pr-#) was confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking - equipment category, other.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.Consumer reports she 'got a blister' from a wrap she wore.The cause of the blister 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.This batch t26686 was involved in investigation (b)(4)-t26691, t26693, t26686 & s68516 menstrual & muscle joint us- cells damaged/leaking.The batch was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4) for cell pack damage/leaking.This current complaint does not involve cell damage/leaking.Process related: no; complaint confirmed: no.Site sample status: received at the site.Date samples were received: 15nov2018.Return sample evaluation: two muscle and joint wraps - wraps show no evidence of wear.The wraps are expired.The cell packs are hard; evidence of brine dosing.Two m&j pouches - pouches are open.(l) t26686, (b)(6),exp jul2020 22:57; one m&j carton - carton is open (l) t26686, (b)(6), exp jul2020 23:39.

Event Description

Event verbatim [preferred term] blisters [blister].Narrative: this is a spontaneous report from a contactable consumer (patient).A 76-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number t26686, expiration date jul2020, udi number: (b)(4), since an unspecified date (too many years ago, it had been 5 or 6 years ago) at unknown frequency for muscle pain, shoulder pain, and elbow pain.Medical history included torn rotator cuff from an unknown date and unknown if ongoing and shrunk two and a half inches (when the patient was 30 years old she was 5 foot 11 and now she was 76 and she was 5 foot seven and a half).There were no concomitant medications.The patient stated, she had a box of the thermacare she got a letter from the (club name) where she bought it, it was on a recall.The patient mentioned no doctor prescribed it to her.She used it ((thermacare heatwraps multi-purpose muscle pain) before until she got to a doctor.The patient stated, she had a torn rotator cuff, she had elbow that needed to be replace it was bone on bone, she had pain.That was why she used these (thermacare heatwraps multi-purpose muscle pain).The patient further stated, "it's bone on bone it needs replaced.I don't want to do it right now.My orthopedic doctor gives me injection in it every so often just like he gives me injections in my shoulder." the patient experienced blisters on (b)(6) 2018.The patient stated that she didn't have that box, she got a blister from.She threw the thing away that was after she threw it away she discovered she had the blister, and then yesterday ((b)(6) 2018) she got the letter and today ((b)(6) 2018) she looked at her packages and she still had one at the package with a batch number on it.But she had the unopened one (recalled box).The patient stated, she hadn't looked at it yet since, it was still there, it hadn't burst yet this morning (on (b)(6) 2018).The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not resolved.According to the product quality complaint group: batch t26686 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the three pouched wraps inside.Inspection shows no obvious defects to the cartons or pouched wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 07nov2018.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the (site name) requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint of adverse event.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per (b)(4); effective date: 04aug2017.Shiftly production transition notes were reviewed.There were no issues noted in the heat pack maker portion of the line that would have caused cells to be damaged or leaking or affect the wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.One previous complaint (#-us, pr-#) was confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking - equipment category, other.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.Consumer reports she 'got a blister' from a wrap she wore.The cause of the blister 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.This batch t26686 was involved in investigation (b)(4)-t26691, t26693, t26686 & s68516 menstrual & muscle joint us- cells damaged/leaking.The batch was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4) for cell pack damage/leaking.This current complaint does not involve cell damage/leaking.Process related: no; complaint confirmed: no.Site sample status: received at the site.Date samples were received: 15nov2018.Return sample evaluation: two muscle and joint wraps - wraps show no evidence of wear.The wraps are expired.The cell packs are hard; evidence of brine dosing.Two m&j pouches - pouches are open.(l) t26686, (b)(6), exp jul2020 22:57; one m&j carton - carton is open (l) t26686, (b)(6), exp jul2020 23:39.No follow-up attempts are possible.No further information is expected.Follow-up (08nov2018): new information reported from the pqc group includes: product investigation summary results.No follow-up attempts are possible.No further information is expected.Follow-up (18oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (18sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the event blisters 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.

• 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
• MDR Report Key: 9260669
• MDR Text Key: 167785634
• Report Number: 1066015-2019-00367
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 305733013038
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Lot Number: T26686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 120