MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number U-8413

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Class/sub class: external cause investigation | adverse event safety request for investigation.This investigation was conducted for an unknown lot number lower back/hip 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.

Event Description

Applied directly to skin [device use error], they were irritating [skin irritation], they left a splotch [skin discolouration], were a little irritating, like they were burning [skin burning sensation].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) male patient started to use thermacare heatwrap (thermacare heatwrap) lot number u-8413, from an unspecified date and ongoing for lower back knee pain.The patient's medical history was not reported.Concomitant medication included menthol, methyl salicylate (salonpas), acetylsalicylic acid (aspirin) 81 mg, naproxen sodium (aleve), colecalciferol (vitamin d), probiotics and docusate sodium (stool softener).On an unspecified date, the patient reported the last batch of heatwraps were a little irritating, like they were burning.He reported they left a "splotch".He stated he did not use the wrap over clothing as he was (b)(6) and had never had to wear the wrap over clothing.He applied directly to skin.No one every told to apply over clothing.The product was discarded by the patient.A physician stated that the patient did not provide information to him/her regarding the reported adverse events with the use of the product.Action taken with the suspect product was unknown.No treatment was received for the events they were irritating, they left a splotch, were a little irritating, like they were burning.Clinical outcome of the events was resolved.According to product quality complaint group, class/sub class: external cause investigation | adverse event safety request for investigation.This investigation was conducted for an unknown lot number lower back/hip 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.Additional information received from pqc: severity of harm: s3.Dchu conclusion: based on the complaint narrative, the patient sustained skin irritation and had splotchy skin after product use.Review of complaint description concludes there is no device malfunction.Follow-up (23may2019): new information received from a contactable consumer included: patient age, suspect product data (lot number, indication), concomitant medications, new event (applied directly to skin), deny of treatment received and event outcome.Follow-up (14jun2019): new information received from a contactable physician includes new reporter and deny of acknowledge of the events.Follow-up attempts are completed.No further information is expected.Follow-up (01aug2019): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Follow up (15aug2019 and 15oct2019): new information received from a product quality complaint group includes: dchu malfunction and severity assessment.This case was upgraded to a serious and reportable mdr.Company clinical evaluation comment: based on the information provided, the events device use error, skin irritation, skin discolouration and skin burning sensation 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.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 device use error, skin irritation, skin discolouration and skin burning sensation 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.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 HEATWRAP
• 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: 9444802
• MDR Text Key: 186598235
• Report Number: 1066015-2019-00531
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: U-8413
• Was Device Available for Evaluation?: No
• 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: 78 YR