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

Lot Number S37617

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

Patient Problems Erythema (1840); Pain (1994); Complaint, Ill-Defined (2331); Impaired Healing (2378)

Event Date 03/15/2018

Event Type  Injury  

Event Description

After applying the pad unpleasant feeling, redness and blisters under the pad/painful blisters [blister], after applying the pad unpleasant feeling, redness and blisters under the pad [malaise], after applying the pad unpleasant feeling, redness and blisters under the pad [erythema], painful blisters [pain], have only badly healed [impaired healing],.Case narrative: this is a spontaneous report from a contactable pharmacist via (b)(6).A (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder and wrist) lot no s 3761701/04, expiration date dec2019, from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient bought a six pack of thermacare neck, shoulder and wrist.After applying the pad she noticed an unpleasant feeling, redness and blisters under the pad on (b)(6) 2018.She brought it back to the pharmacy.The patient applied the wrap on her shoulder during the day.It was removed in the evening, painful blisters formed, which have only badly healed.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wrap caused burned blisters on the skin".The cause of the burn 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.

Event Description

Event verbatim [preferred term] after applying the pad unpleasant feeling, redness and blisters under the pad/painful blisters/heat wrap caused burned blisters on the skin/ blisters burst open, very painfully when lying on back [burns second degree] , after applying the pad unpleasant feeling, redness and blisters under the pad [malaise] , have only badly healed [impaired healing],.Case narrative: this is a spontaneous report from (b)(6).(b)(4).A contactable pharmacist reported a (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: s37617, expiration date: dec2019) from (b)(6) 2018 17:00 at 1 wrap once daily for neck tightness.Medical history was not reported.Concomitant medications were none.The patient bought a sixpack of thermacare heatwrap.The patient applied the wrap on her shoulder during the day.After applying the pad she noticed an unpleasant feeling, redness and blisters under the pad on (b)(6) 2018.It was removed in the evening, painful blisters formed, which have only badly healed.The patient experienced burns with blister development (2 cm raised) on the whole application area.Blisters burst open, very painfully when lying on back, no ointment or anything applied, let them dry out and heal by themselves.She brought it back to the pharmacy.The action taken in response to the events for thermacare heatwrap was permanently discontinued.The outcome of burns with blister was resolved after 4 weeks (2018).The outcome of other events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wrap caused burned blisters on the skin".The cause of the burn 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.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2018): new information received from product quality complaint group includes investigation results.In addition, subsumed "heat wrap caused burned blisters on the skin" into "after applying the pad unpleasant feeling, redness and blisters under the pad/painful blisters", recoded to burn blister, and removed events redness and pain.Follow-up (17apr2018): new information received from a contactable pharmacist includes: patient data (weight, height), suspect product data (start date, stop date, dosage, indication, action taken), deny of concomitant medications and treatment received, event details and updated event outcome.

Event Description

Event verbatim [preferred term] after applying the pad unpleasant feeling, redness and blisters under the pad/painful blisters/heat wrap caused burned blisters on the skin [burns second degree], after applying the pad unpleasant feeling, redness and blisters under the pad [malaise], have only badly healed [impaired healing], case narrative: this is a spontaneous report from bundesinstitut fur arzneimittel und medizinprodukte (bfarm).The regulatory authority report number is (b)(4).A contactable pharmacist reported a (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: s37617, expiration date: dec2019) from an unknown date for an unknown indication.Medical history and concomitant medications were not reported.The patient bought a sixpack of thermacare heatwrap.After applying the pad she noticed an unpleasant feeling, redness and blisters under the pad on (b)(6) 2018.She brought it back to the pharmacy.The patient applied the wrap on her shoulder during the day.It was removed in the evening, painful blisters formed, which have only badly healed.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wrap caused burned blisters on the skin".The cause of the burn 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.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2018): new information received from product quality complaint group includes investigation results.In addition, subsumed "heat wrap caused burned blisters on the skin" into "after applying the pad unpleasant feeling, redness and blisters under the pad/painful blisters", recoded to burn blister, and removed events redness and pain.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "heat wrap caused burned blisters on the skin".The cause of the burn 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.

• 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
• MDR Report Key: 7384786
• MDR Text Key: 103938609
• Report Number: 1066015-2018-00045
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

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: S37617
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2018; 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR