MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number N15180

Device Problem Fitting Problem (2183)

Patient Problems Loss of Range of Motion (2032); Skin Irritation (2076); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term] mild burn, reddened area/redness/caused the skin to get hotter [thermal burn] , redness and irritation [skin irritation] , this tighter fit allows no air to infiltrate/consumer alleges wrap was too hot [device issue] , can't move neck [nuchal rigidity] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number n15180, expiration date jan2019, via an unspecified route of administration from an unspecified date for an unspecified indication.Medical history included cervical disc degeneration.The patient's concomitant medications were not reported.The patient previously used thermacare heatwrap (thermacare heatwrap) for years with no problem.The patient had used the old design for years with no problem.She used the product with the new design the first time on (b)(6) 2016.She used the product for six hours, and when she removed it noticed a mild burn, a reddened area.It was very mild and not blistered.It was the size of the wrap.She put first aid cream on it.The patient also reported could not move neck on an unknown date.Upon follow up she reported the new design of the neck pads places them more tightly against the skin than the old design.While seemingly helpful, this tighter fit allowed no air to infiltrate, caused the skin to get hotter and for her, it caused redness and irritation of the area on an unspecified date.The action taken of the product was stopped.The outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (18may2016): new information received from a contactable consumer included past product history, reaction data (additional event of causes the skin to get hotter and irritation) and the product complaint "the new design of the neck pads places them more tightly against the skin than the old design".Follow-up attempts completed.No further information expected.Follow-up (23jun2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts completed.No further information expected.Follow-up (11may2016): 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 thermal burn, skin irritation, and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event nuchal rigidity is non-serious.The events are 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 device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events thermal burn, skin irritation, and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event nuchal rigidity is non-serious.The events are 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 device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• 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: 9257091
• MDR Text Key: 180696319
• Report Number: 1066015-2019-00270
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Lot Number: N15180
• 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: 67 YR
• Patient Weight: 75