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

Lot Number AA2376

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Discomfort (2330)

Event Type  Injury  

Event Description

Did dig in the skin [skin irritation] , it was really uncomfortable [discomfort].Case narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aa23761219, expiration date nov2021, 2-pack) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a 2-pack from the local store.When applying the first wrap, it did dig in the skin and she could not use it, it was really uncomfortable.Thermacare heatwrap was temporarily withdrawn on an unknown date in response to the events.The clinical outcome of the events was unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events skin irritation and discomfort as described are considered serious bodily injury potentially 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 skin irritation and discomfort as described are considered serious bodily injury potentially 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.

Event Description

Event verbatim [preferred term] did dig in the skin [skin irritation] , it was really uncomfortable [discomfort].Case narrative:this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aa23761219, expiration date nov2021, 2-pack) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a 2-pack from the local store.When applying the first wrap, it did dig in the skin and she could not use it, it was really uncomfortable.Thermacare heatwrap was temporarily withdrawn on an unknown date in response to the events.The clinical outcome of the events was unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2020): new information received from a contactable consumer includes: the consumer declined any further correspondence as she reported she had given all the information she wished.Company clinical evaluation comment: based on the information provided, the events skin irritation and discomfort as described are considered serious bodily injury potentially 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 skin irritation and discomfort as described are considered serious bodily injury potentially 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.

Event Description

Did dig in the skin [skin irritation].It was really uncomfortable [discomfort].Case description: this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aa23761219, expiration date nov2021, 2-pack) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a 2-pack from the local store.When applying the first wrap, it did dig in the skin and she could not use it, it was really uncomfortable.Thermacare heatwrap was temporarily withdrawn on an unknown date in response to the events.The clinical outcome of the events was unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2020): new information received from a contactable consumer includes: the consumer declined any further correspondence as she reported she had given all the information she wished.Follow-up (07apr2020): this follow-up report is being submitted to amend previously reported information: the case has been considered non-serious non-reportable.

Event Description

Event verbatim [preferred term], did dig in the skin/dug into her ribs [skin irritation], it was really uncomfortable [discomfort], , narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unknown age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number aa2376, expiration date nov2021, 2-pack) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a 2-pack from the local store.When applying the first wrap, it did dig in the skin and she could not use it, it was really uncomfortable.The patient also said it was uncomfortable to wear, patch dug into her ribs.The action taken in response to the events of thermacare heatwrap was temporarily withdrawn on an unknown date.The clinical outcome of the events was unknown.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports she wrap "digs into her ribs." the cause of the consumer stating the wrap "digs into her ribs" 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 assessment: no trend identified for this batch: an analysis of the complaint history confirms that this is the first complaint about the subclass adverse event/serious/unknown defect received at the albany site requiring evaluation for this batch.Based on this review, a trend does not exist for this batch.Sample was not received.Reasonably suggest device malfunction was yes.Severity of harm was s2.Follow-up (13mar2020): new information received from a contactable consumer includes: the consumer declined any further correspondence as she reported she had given all the information she wished.Follow-up (07apr2020): this follow-up report is being submitted to amend previously reported information: the case has been considered non-serious non-reportable.Follow-up (28jul2020): new information received from the product quality complaint group includes device data (updated lot number, sample status), clinical event course, severity rating, malfunction assessment and investigational results.Follow up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2020-00053 and mfr report number 1066015-2020-00100 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2020-00053.Mfr report number 1066015-2020-00100 is to be considered as deleted.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports she wrap "digs into her ribs." the cause of the consumer stating the wrap "digs into her ribs" 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 assessment: no trend identified for this batch: an analysis of the complaint history confirms that this is the first complaint about the subclass adverse event/serious/unknown defect received at the albany site requiring evaluation for this batch.Based on this review, a trend does not exist for this batch.Sample was not received.Reasonably suggest device malfunction was yes.Severity of harm was s2.

• 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: 9780708
• MDR Text Key: 190338847
• Report Number: 1066015-2020-00053
• 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,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Lot Number: AA2376
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention