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

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

Patient Problem Injury (2348)

Event Date 04/22/2020

Event Type  Injury  

Event Description

Injuries [injury].Narrative: this is a spontaneous report from a contactable lawyer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number and expiration date not provided, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced injuries on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].Injuries [injury], narrative: this is a spontaneous report from a contactable lawyer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported the patient sustained unspecified injuries on (b)(6) 2020.Action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (11jun2020): new significant information received from an attorney includes: event onset date.Amendment: this follow-up report is being submitted to amend previously reported information: updated reaction data (event onset date).

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 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, 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/serious/unknown.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.Site had not received the sample.Severity of harm was s3.

Event Description

Event verbatim [preferred term].Injuries [injury].Narrative: this is a spontaneous report from a contactable lawyer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported the patient sustained unspecified injuries on (b)(6) 2020.Action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Follow-up (11jun2020): new significant information received from an attorney includes: event onset date.Amendment: this follow-up report is being submitted to amend previously reported information: updated reaction data (event onset date).Follow-up (30aug2020): according to product quality complaint group: summary of investigation was this investigation was conducted for an unknown lot number lower back/hip (lbh) 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, 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/serious/unknown.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.Site had not received the sample.Severity of harm was s3.

• 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: 10159557
• MDR Text Key: 195373066
• Report Number: 1066015-2020-00131
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention