MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FUER FLEXIBLE ANWENDUNG; DISPOSABLE PACK, HOT

Lot Number T65599

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Dizziness (2194); Collapse (2416)

Event Date 10/22/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] but then i got a circulatory collapse (dizziness, nausea) [circulatory collapse] , pain has suddenly become extremely intense approximately 3 minutes after the wrap was applied [back pain] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6)-year-old male patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t65599, expiration date aug2020) from (b)(6) 2019 at 1 wrap for lumbago.The patient's medical history was not reported.Concomitant medication included diclofenac (diclofenac) and pantoprazole (pantoprazol [pantoprazole]).On (b)(6) 2019, the patient reported "the pain that was supposed to be relieved has suddenly become extremely intense.This happened approximately 3 minutes after the wrap was applied to the lower back/hip.After i removed the wrap, the pain was immediately reduced.But then i got a circulatory collapse (dizziness, nausea) and had to lie down.Afterwards, however, the general condition improved again".Action taken with the suspect product was unknown.Clinical outcome of the events was resolving.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event circulatory collapse as described is considered serious medical condition.Event back pain is non-serious.A causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available., comment: based on the information provided, the event circulatory collapse as described is considered serious medical condition.Event back pain is non-serious.A causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the lot thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "i got a circulatory collapse (dizziness, nausea) and had to lie down".The cause of the consumer reporting dizziness and nausea from the wrap 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 dhr from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.The lot t65599 is the only lot within the scope of this investigation.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.Severity of harm: s3.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient developed intense pain in the area the device was being used to relieve pain while using the product.The patient also developed dizziness and nausea with product use.The symptoms subsided after stopping the use of the device.Review of complaint description concludes there is no device malfunction.

Event Description

Event verbatim [preferred term] but then i got a circulatory collapse (dizziness, nausea) [circulatory collapse] , pain has suddenly become extremely intense approximately 3 minutes after the wrap was applied [back pain].Case narrative:this is a spontaneous report from a contactable consumer.A 40-year-old male patient started to use thermacare heatwrap (thermacare fuer flexible anwendung) (device lot number t65599, expiration date aug2020) from (b)(6) 2019 at 1 wrap for lumbago.Thermacare was used once on (b)(6) 2019 and is not used anymore.The patient's medical history was not reported.Concomitant medication were not reported.On (b)(6) 2019, the patient reported "the pain that was supposed to be relieved has suddenly become extremely intense.This happened approximately 3 minutes after the wrap was applied to the lower back/hip.After i removed the wrap, the pain was immediately reduced.But then i got a circulatory collapse (dizziness, nausea) and had to lie down.Afterwards, however, the general condition improved again".No hospitalization or treatment was required for the events.Action taken with the suspect product was permanently withdrawn.Clinical outcome of the events was recovered.After discontinuation of thermacare heatwrap, the patient used injection for lumbago, diclofenac 50 mg and pantoprazol.Per the product quality group: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the lot thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "i got a circulatory collapse (dizziness, nausea) and had to lie down".The cause of the consumer reporting dizziness and nausea from the wrap 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 dhr from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.The lot t65599 is the only lot within the scope of this investigation.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.Severity of harm: s3.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient developed intense pain in the area the device was being used to relieve pain while using the product.The patient also developed dizziness and nausea with product use.The symptoms subsided after stopping the use of the device.Review of complaint description concludes there is no device malfunction.Additional information has been requested and will be provided as it becomes available.Follow-up (08nov2019): new information received from the product quality group includes: investigation summary.Follow-up (11dec2019): new information received from the contactable consumer included: updated events (circulatory collapse and acute back pain: no hospitalization or treatment was required.The patient has recovered from the events.), updated suspect product (thermacare was used once on (b)(6) 2019 and is not used anymore).Concomitant medication deleted (treatments started on (b)(6) t2019 ( the day after thermacare discontinuation and adverse event onset) and all not ongoing: injection for lumbago, diclofenac 50 mg and pantoprazol).Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event circulatory collapse as described is considered serious medical condition.Event back pain is non-serious.A causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.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.

Event Description

Event verbatim [preferred term] but then i got a circulatory collapse (dizziness, nausea) [circulatory collapse] , pain has suddenly become extremely intense approximately 3 minutes after the wrap was applied [back pain] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 40-year-old male patient started to use thermacare heatwrap (thermacare heatwrap flexible use) (device lot number t65599, expiration date aug2020) from (b)(6) 2019 to (b)(6) 2019 at 1 wrap for lumbago.The patient's medical history was not reported.Concomitant medication included diclofenac (diclofenac) and pantoprazole (pantoprazol [pantoprazole]).On (b)(6) 2019, the patient reported "the pain that was supposed to be relieved has suddenly become extremely intense.This happened approximately 3 minutes after the wrap was applied to the lower back/hip.After i removed the wrap, the pain was immediately reduced.But then i got a circulatory collapse (dizziness, nausea) and had to lie down.Afterwards, however, the general condition improved again".Action taken with the suspect product was unknown.Clinical outcome of the events was resolving.Per the product quality group: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the lot thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "i got a circulatory collapse (dizziness, nausea) and had to lie down".The cause of the consumer reporting dizziness and nausea from the wrap 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 dhr from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.The lot t65599 is the only lot within the scope of this investigation.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.Severity of harm: s3.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient developed intense pain in the area the device was being used to relieve pain while using the product.The patient also developed dizziness and nausea with product use.The symptoms subsided after stopping the use of the device.Review of complaint description concludes there is no device malfunction.Additional information has been requested and will be provided as it becomes available.Follow-up (08nov2019): new information received from the product quality group includes: investigation summary.Company clinical evaluation comment: based on the information provided, the event circulatory collapse as described is considered serious medical condition.Event back pain is non-serious.A causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.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 event circulatory collapse as described is considered serious medical condition.Event back pain is non-serious.A causal relationship between the suspect device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.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.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the lot thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "i got a circulatory collapse (dizziness, nausea) and had to lie down".The cause of the consumer reporting dizziness and nausea from the wrap 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 dhr from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.The lot t65599 is the only lot within the scope of this investigation.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.Severity of harm: s3.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient developed intense pain in the area the device was being used to relieve pain while using the product.The patient also developed dizziness and nausea with product use.The symptoms subsided after stopping the use of the device.Review of complaint description concludes there is no device malfunction.

• Brand Name: THERMACARE FUER FLEXIBLE ANWENDUNG
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9250501
• MDR Text Key: 167646928
• Report Number: 1066015-2019-00252
• 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
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Lot Number: T65599
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DICLOFENAC; DICLOFENAC; PANTOPRAZOL [PANTOPRAZOLE]; PANTOPRAZOL [PANTOPRAZOLE]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR