MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number DX6580

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

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Event verbatim [preferred term].After half a day the skin at the top edge of the wrap was bloody and scraped [skin haemorrhage], after half a day the skin at the top edge of the wrap was bloody and scraped [skin abrasion], narrative: this is a spontaneous report from a contactable pharmacist received by (b)(6).An about (b)(6) year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number dx6580, expiration date 30apr2023, via an unspecified route of administration from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced after half a day the skin at the top edge of the wrap was bloody and scraped on an unspecified date.The action taken in response to the event and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] after half a day the skin at the top edge of the wrap was bloody and scraped [skin haemorrhage], after half a day the skin at the top edge of the wrap was bloody and scraped [skin abrasion], , narrative: this is a spontaneous report from a contactable pharmacist received by pfizer from (b)(6) pharma.An about 40-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number dx6580, expiration date 30apr2023, via an unspecified route of administration from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced after half a day the skin at the top edge of the wrap was bloody and scraped on an unspecified date.The action taken in response to the event and event outcome was unknown.Additional information received from product quality complaint (pqc) group included investigation results for complaint sub-class: adverse event safety request for investigation.Summary of investigation: batch dx6580 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the device history record (dhr) thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "skin on the upper edge of the patch was bloody and grazed after half a day".The cause of the skin on the upper edge of the patch was bloody and grazed after half a day is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.Per sop 105746 compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result of 8 was below the upper control limit (ucl) of 33.9.Per sop-105746, a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend identified?: no.Site sample status: not received.Follow-up (15jan2021): follow-up attempts completed.No further information expected.Follow-up (22jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Summary of investigation: batch dx6580 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the device history record (dhr) thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "skin on the upper edge of the patch was bloody and grazed after half a day".The cause of the skin on the upper edge of the patch was bloody and grazed after half a day is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.Per sop 105746 compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result of 8 was below the upper control limit (ucl) of 33.9.Per sop-105746, a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend identified?: no.Site sample status: not received.

Manufacturer Narrative

Summary of investigation: batch dx6580 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the device history record (dhr) thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "skin on the upper edge of the patch was bloody and grazed after half a day".The cause of the skin on the upper edge of the patch was bloody and grazed after half a day is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.Per sop (b)(4) compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result of 8 was below the upper control limit (ucl) of 33.9.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend identified?: no.Site sample status: not received.

Event Description

Event verbatim [preferred term] after half a day the skin at the top edge of the wrap was bloody and scraped [skin haemorrhage], after half a day the skin at the top edge of the wrap was bloody and scraped [skin abrasion].Narrative: this is a spontaneous report from a contactable pharmacist received by pfizer from angelini pharma.A 49-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number dx6580, expiration date 30apr2023, via an unspecified route of administration from an unspecified date at unknown frequency for an unspecified indication.The patient medical history was not reported.There were no concomitant medications.The patient experienced after half a day the skin at the top edge of the wrap was bloody and scraped on an unspecified date.It was used not for a first time.The action taken in response to the event was permanently withdrawn on an unspecified date.The event outcome was resolving.The events were assessed as medically significant, related to the device.Additional information received from product quality complaint (pqc) group included investigation results for complaint sub-class: adverse event safety request for investigation.Summary of investigation: batch dx6580 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the device history record (dhr) thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "skin on the upper edge of the patch was bloody and grazed after half a day".The cause of the skin on the upper edge of the patch was bloody and grazed after half a day is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.Per sop (b)(4) compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result of 8 was below the upper control limit (ucl) of 33.9.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend identified?: no.Site sample status: not received.Follow-up (15jan2021): follow-up attempts completed.No further information expected.Follow-up (22jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (25jan2021): new information received from the contactable pharmacist included: patient age, no concomitant medications, action taken, event details (including event outcome), and assessment from the reporter (the events were assessed as medically significant, related to the device).Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11140102
• MDR Text Key: 225779810
• Report Number: 1066015-2021-00006
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Lot Number: DX6580
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 73