MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number S16673

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "she had a skin infection".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.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.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] skin infection, redness on her ankle and leg, on the left side [skin infection].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) device lot number s16673, expiration date dec2019, from (b)(6) 2018 to (b)(6) 2018 for ankle pain.Medical history was reported as none.There were no concomitant medications.Consumer called because she received a letter stating the product had been recalled and she wanted to know if the recall was related to her skin infection.In (b)(6) 2018, the patient experienced redness on her ankle and leg on the left side.She stated the strangest thing happened.She had a skin infection on (b)(6) 2018 and she had it for a week and had to go to the hospital.She went to the emergency room but was not admitted.She was now on antibiotics sulfamethoxazole/trimethoprim (bactrim) and cephalexin.Therapeutic measures for the events included antibiotics, bactrim and cephalexin.It was unknown yet if she had permanent damage, her skin was red and infected.Thermacare heatwrap package '2 or 3 count' was sealed and intact.A sample of the product was available for return.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in (b)(6) 2018.Clinical outcome of the event was resolving.Consumer reported that it was possibility that the adverse event skin infection was related to the device.As of (b)(6) 2019, according to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "she had a skin infection".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.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.The product quality for the batch is not impacted by this complaint.Follow up ((b)(6) 2019): new information received from the product quality complaint group includes investigational results.Follow-up ((b)(6) 2019): follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2018): 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 event of skin infection (redness on her ankle and leg, on the left side)" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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 further investigations or actions is suggested at this time., comment: based on the information provided, the event of skin infection (redness on her ankle and leg, on the left side)" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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 further investigations or actions is suggested at this time.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• 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: 9260678
• MDR Text Key: 164865896
• Report Number: 1066015-2019-00356
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Lot Number: S16673
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 81