MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number T98298

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wraps are "rolling up on her ".The cause of the wrap rolling up 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.The root cause category is non-assignable (complaint not confirmed as a quality complaint).The evaluation of the returned sample does not show any obvious defects to the wrap.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.

Event Description

Event verbatim [preferred term] the older ones used to last up to 8 hours and still had some heat when removed it/ don't generate the same amount of heat/the new ones the heat is gone after about 6 hours/ not hitting the same spot [device issue], this product gave her a nice and soothing relief, but the new ones didn't seem to give that effect, not like the old design [device ineffective], used to be 5' 5 1/2", but that was not since the thermacare heatwrap use (current height 5 feet, 5 inches) [body height decreased].Case narrative: the initial case was missing the following minimum criteria: no adverse effect.Upon receipt of follow-up information on 04dec2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable nurse reporting for herself.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t98298, expiration date jan2021, upc number: (b)(4), via an unspecified route of administration from an unspecified date and ongoing for low back pain and back spasm.Medical history included osteopenia for years.There were no concomitant medications.The reporter firstly reported the wraps were not heating like they normally do; didn't have the same heat intensity.As of 04dec2018, the reporter reported she has been using the thermacare heatwraps for years and as of late, these new and better fit ones have been rolling up on her now and they didn't generate the same amount of heat as the other old ones.The piece under the abdomen rolls ups, bunches up, and cuts into you and the old ones are not like that.The spread or areas where the disc were located are not hitting the same spot.She used to be 5' 5 1/2", but that was not since the thermacare heatwrap use (current height 5 feet, 5 inches), she had osteopenia for years.She had a bone density done.She has noticed the fit and lack of heat this past year since they came out with the new and better fit for more targeted relief, thermacare lower back and hip wraps.She just put it on during the day for about 6-8 hours.The older ones used to last up to 8 hours and still had some heat to it when she removed it, but with the new ones the heat is gone after about 6 hours.She has gone through 3-4 boxes of the new ones and they all had the same effect.Reporter unable to provide any product details for those other 3-4 boxes such as the ndc, upc, lot, or expiration date.After she uses them she throws them in the recycle bin.She has back spasm and this product gave her a nice and soothing relief, but the new ones didn't seem to give that effect, not like the old design.The action taken for the product was dose not changed.The outcome of the event "used to be 5' 5 1/2", but that was not since the thermacare heatwrap use (current height 5 feet, 5 inches)" was unknown.The outcome of the other events was not resolved.According to the product quality complaint group: investigation summary: after a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wraps are "rolling up on her ".The cause of the wrap rolling up 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.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality complaint).The evaluation of the returned sample does not show any obvious defects to the wrap.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.Follow-up (15jan2019 and 16jan2019): new information received from product quality complaint group includes investigation results.Follow-up (19feb2019 and 20feb2019): new information received from product quality complaint group includes investigation results.Follow-up (05apr2019): follow-up attempts are completed.No further information is expected.Follow-up (04dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on available information, the patient reported "the older ones used to last up to 8 hours and still had some heat when removed it/ don't generate the same amount of heat/the new ones the heat is gone after about 6 hours/ not hitting the same spot" which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The reported events are non-serious.The events are medically assessed as associated with the use of the device., comment: based on available information, the patient reported "the older ones used to last up to 8 hours and still had some heat when removed it/ don't generate the same amount of heat/the new ones the heat is gone after about 6 hours/ not hitting the same spot" which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The reported events are non-serious.The events are medically assessed as associated with the use of the device.

• Brand Name: THERMACARE LOWER BACK & HIP
• 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: 9259949
• MDR Text Key: 220572840
• Report Number: 1066015-2019-00354
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 305733010037
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

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: 01/01/2021
• Device Lot Number: T98298
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 71 YR
• Patient Weight: 78