MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

Lot Number R23409

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The review of raw material (sca) records and in process sampling data does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.The product effect may vary with each individual.The sca laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.There were no sca laminate material problems detected during the in process wrap attribute testing completed while this batch was being produced.There were no supplier incident forms completed for the batches of sca laminate material used in manufacturing of this batch.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.The root cause category is non assignable (complaint not confirmed).The review of raw material (company name) records and in process sampling data does not provide evidence to support defective product.(company name) passed all criteria for release for use in manufacturing.The product effect may vary with each individual.The (company name) is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.There were no (company name) material problems detected during the in process wrap attribute testing completed while this batch was being produced.There were no supplier incident forms completed for the batches of (company name) material used in manufacturing.

Event Description

Sticky part pulled skin off/ripped her skin off/ripped the top layer of skin/the top layer of skin that peeled off [skin abrasion], the burning sensation started/pain [skin burning sensation], she was sitting on her couch and leaned forward to pet her cat and one side ripped off and she thought she had it too tight [device use error], sticky part pulled skin off/there was a sticky adhesive part on each side of the heatwraps/she thought she had it too tight [device adhesion issue], had a horrible night of sleep because every movement hurt/ it made sleep and work impossible for 2 days [insomnia].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare muscle & joint) (device lot number r23409, expiration date sep2019) from an unspecified date at 1 patch for 2 hours for back spasming, back pain/ back hurt.Medical history included multiple sclerosis from 2010 and ongoing, broken neck from an unknown date and unknown if ongoing, falling down stairs from an unknown date and unknown if ongoing.There were no concomitant medications.On (b)(6) 2017, the patient reported when she took off the heatwrap the sticky part pulled her skin off.The patient's skin was still attached to the wrap.She was going to get a lawyer or have pfizer pay for her bills.There was a sticky adhesive part on each side of the heatwraps.She was sitting on her couch and leaned forward to pet her cat and one side ripped off and she thought she had it too tight and tried to put it on a little looser and then realized it was off center and then tried to center it.Then, her shirt touched her skin and the burning sensation started.She clarified her shirt grazed her skin and she realized it ripped her skin off and skin was on the sticky tape in the exact same pattern.One side was a big one of skin and the other side was three small areas.This happened at 11:00pm last night ((b)(6) 2017).The pharmacy told her to put aloe, like she would on a sunburn, and she did and then went to bed.She had a horrible night of sleep because every movement hurt.She had used the product probably 100 times and never had an issue with the product.She did not know what happened.Caller stated it will heal on its own and was not going to require medical attention or be permanent, but was the product's fault.Caller stated there was no need for medical case as it only ripped the top layer of skin, however it made sleep and work impossible for 2 days due to the pain and the location.The patient was not hospitalized for the events "sticky part pulled skin off/ripped her skin off", "sticky part pulled skin off", but received treatment of antibiotic cream applied.The patient was not hospitalized and did not receive treatment for the events "the burning sensation started" and "had horrible night sleep because every movement hurt".Upon follow-up, the patient reported 'they ripped the skin of my back in (b)(6) 2018', but didn't specify which product they are referring to.In reference to thermacare heatwrap, the patient stated it was the top layer of skin that peeled off with the patch and she just had to let it heal.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events "sticky part pulled skin off/ripped her skin off/ripped the top layer of skin", "sticky part pulled skin off", "burning sensation started", "had a horrible night of sleep because every movement hurt" "she was sitting on her couch and leaned forward to pet her cat and one side ripped off and she thought she had it too tight" was resolved on an unspecified date.Upon follow-up, the product quality complaints group revealed that the suspect product was actually thermacare heatwrap (thermacare muscle & joint heatwrap 8hr) and not thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) based on the lot number r23409.The root cause category is non assignable (complaint not confirmed).The review of raw material (sca) records and in process sampling data does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.The product effect may vary with each individual.The sca laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.There were no sca laminate material problems detected during the in process wrap attribute testing completed while this batch was being produced.There were no supplier incident forms completed for the batches of sca laminate material used in manufacturing of this batch.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.According to product quality complaint group: the root cause category is non assignable (complaint not confirmed).The review of raw material (company name) records and in process sampling data does not provide evidence to support defective product.(company name) passed all criteria for release for use in manufacturing.The product effect may vary with each individual.The (company name) is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.There were no (company name) material problems detected during the in process wrap attribute testing completed while this batch was being produced.There were no supplier incident forms completed for the batches of (company name) material used in manufacturing of this batch.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Follow-up (23jan2018): new information reported from the product quality complaints group includes: investigative results.Follow-up (24jul2018): new information received from a contactable consumer includes: dose, indication, action taken, events treatment and outcome, none concomitant medications.The patient was not hospitalized.Added new events "it made sleep impossible for 2 days".No follow-up attempts are possible.No further information is expected.Follow-up (18dec2018): new information received from a product quality complaint group included: investigation results.Follow-up (19mar2019 and 21mar2019): new information received from the contactable consumer and product quality complaint group includes: event information and product information.Follow-up attempts are completed.No further information is expected.Follow-up (27dec2017): 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 skin abrasion, skin burning sensation, device use error and device adhesion issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event insomnia is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events skin abrasion, skin burning sensation, device use error and device adhesion issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event insomnia is non-serious.The events are medically assessed as associated with the use of the device.

• Brand Name: THERMACARE MUSCLE & JOINT
• 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: 9259932
• MDR Text Key: 185000663
• Report Number: 1066015-2019-00359
• 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: 12/27/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2019
• Device Lot Number: R23409
• 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
• Patient Age: 43 YR
• Patient Weight: 73