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

Lot Number T48909

Device Problem Material Integrity Problem (2978)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Discoloration (2074); Reaction (2414); Skin Inflammation (2443)

Event Date 01/28/2019

Event Type  Injury  

Event Description

He wore it and got an extreme allergic reaction from it.He got dermatitis [hypersensitivity], [dermatitis].He has a really itchy imprint of the wrap on his back and it is really red [erythema], [pruritus].Imprint of heat cells on his back [skin discolouration].Case narrative: this is a spontaneous report from a contactable consumer reported for her husband.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number t48909, expiration date: sep2020, via an unspecified route of administration from an unspecified date to an unspecified date applied to lower back as needed for an unspecified indication.Relevant medical history was none.Concomitant medications were none.Consumer purchased the thermacare heat wraps for her husband.He wore it and got an extreme allergic reaction from it.He got dermatitis.He has a really itchy imprint of the wrap on his back and it is really red.The heat cells have made an imprint on (b)(6) 2019.He took benadryl and used hydrocortisone cream last night.He was getting ready to go into the hospital to have a procedure done and was upset that there was something wrong with him already.She didn't know what was in them that would cause an allergic reaction.She had used them for years without a problem.The action taken in response to the events of the product was permanently discontinued.The outcome of imprint of heat cells on his back was resolving.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of hypersensitivity, dermatitis, erythema, pruritus and skin discolouration as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "extreme allergic reaction from it" and "itchy imprint of the wrap on his back and it is really red.The heat cells have made an imprint." the cause of the allergic reaction and imprint are 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.

Event Description

Event verbatim [preferred term] he wore it and got an extreme allergic reaction from it.He got dermatitis [hypersensitivity] , he wore it and got an extreme allergic reaction from it.He got dermatitis [dermatitis] , he has a really itchy imprint of the wrap on his back and it is really red [erythema] , he has a really itchy imprint of the wrap on his back and it is really red [pruritus] , imprint of heat cells on his back [skin discolouration] case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A 68-years old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number t48909, expiration date: sep2020, via an unspecified route of administration from an unspecified date to an unspecified date applied to lower back as needed for lower back pain.Relevant medical history was none.Concomitant medications were none.Consumer purchased the thermacare heat wraps for her husband.He wore it and got an extreme allergic reaction from it.He got dermatitis.He has a really itchy imprint of the wrap on his back and it is really red.The heat cells have made an imprint on (b)(6) 2019.He took benadryl and used hydrocortisone cream last night.He was getting ready to go into the hospital to have a procedure done and was upset that there was something wrong with him already.She didn't know what was in them that would cause an allergic reaction.She had used them for years without a problem.The action taken in response to the events of the product was permanently discontinued.The outcome of imprint of heat cells on his back was resolving.The outcome of other events was unknown.According to product quality complaint group, investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "extreme allergic reaction from it" and "itchy imprint of the wrap on his back and it is really red.The heat cells have made an imprint." the cause of the allergic reaction and imprint are 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.Follow-up (14mar2019): new information received from a product quality complaints group included: investigation results.This follow-up report is also being submitted to amend previously reported information: past product use deleted, indication of suspect product added.Company clinical evaluation comment: based on the information provided, the events of hypersensitivity, dermatitis, erythema, pruritus and skin discolouration as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of hypersensitivity, dermatitis, erythema, pruritus and skin discolouration as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.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
• MDR Report Key: 8325218
• MDR Text Key: 135723088
• Report Number: 1066015-2019-00031
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Lot Number: T48909
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 84