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

Lot Number AN9834

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Inflammation (2443); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Event Description

Whole back blistered [blister].Case narrative: this is a spontaneous report from a contactable nurse reported for son.A (b)(6) year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number an9834, expiration date dec2021, via an unspecified route of administration from (b)(6) 2019 to an unspecified date at one heatwrap to lower back because hurt back.Medical history included ongoing hypertension.Concomitant medication was none.A retired nurse reporting on thermacare heatwrap large-xl large, later clarified to be thermacare heatwrap advanced back pain therapy large-xl.This was a two pack.She was calling on behalf of her son who hurt his back at work and applied this heat wrap and his whole back blistered.Initially she stated this occurred two days ago.However, later clarified, the patient applied the heat wrap on (b)(6) 2019 and it was yesterday (b)(6) 2019 that he woke up with whole back blistered.She stated there was not really anything could do except give pain medicine, ibuprofen.The blisters were not open.They followed the line where the heat wrap was placed.They were red.They were dime size to quarter size shape.The product was not available to be returned.It had been tossed.Reporter considered whole back blistered as medically significant.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "blisters" as described is considered serious bodily injury 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 of "blisters" as described is considered serious bodily injury 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.

Event Description

Event verbatim [preferred term] whole back blistered [blister].Case narrative:this is a spontaneous report from a contactable nurse reported for son.A 42-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number an9834, expiration date dec2021, via an unspecified route of administration from (b)(6) 2019 to an unspecified date at one heatwrap to lower back because hurt back.Medical history included ongoing hypertension.Concomitant medication was none.A retired nurse reporting on thermacare heatwrap large-xl large, later clarified to be thermacare heatwrap advanced back pain therapy large-xl.This was a two pack.She was calling on behalf of her son who hurt his back at work and applied this heat wrap and his whole back blistered.Initially she stated this occurred two days ago.However, later clarified, the patient applied the heat wrap on (b)(6) 2019 and it was yesterday (b)(6) 2019 that he woke up with whole back blistered.She stated there was not really anything could do except give pain medicine, ibuprofen.The blisters were not open.They followed the line where the heat wrap was placed.They were red.They were dime size to quarter size shape.The product was not available to be returned.It had been tossed.Reporter considered whole back blistered as medically significant.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was not resolved.According to the product quality complaint group: severity of harm was s3 for complaint sub-class: adverse event/serious/unknown.A summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient developed blisters with product use.Review of complaint description concludes there is no device malfunction.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused red spots, "the patient hurt his back at work and applied this heat wrap and his whole back blistered,".The cause of the wrap causing blisters 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.A trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for m&j products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product.Follow-up (14nov2019 and 26nov2019): new information received from the product quality complaint group includes severity rating, malfunction assessment and investigational results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event of "blisters" as described is considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time, comment: based on the information provided, the event of "blisters" as described is considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused red spots, "the patient hurt his back at work and applied this heat wrap and his whole back blistered,".The cause of the wrap causing blisters 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.A trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for m&j products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product.

• 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
• MDR Report Key: 9363200
• MDR Text Key: 185779460
• Report Number: 1066015-2019-00485
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Lot Number: AN9834
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 100