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

Lot Number M59543

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Defective Device (2588)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

Subclass: cells damaged/leaking.Investigation summary: our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The alleged defective sample have not been received at the site, nor has the requested photographs of alleged defective wrap been attached in pcom.The complaint cannot be confirmed.Review of records does not provide any evidence of defective product.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.Additional information received from the product quality complaint group reported: investigation summary: all in process procedures were followed, and all release criteria met, however, there is the potential for this defect to occur.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Most likely root cause: process defect; an insufficient pouch seal.Pouch sealing defects are being trended for all batches.If a trend is identified for a specific batch further investigation will be conducted.There are two projects in process to decrease/eliminate unsealed or leaking pouches: pouch sealing- engilico equipment- will be added to the flow rapper.It will measure the sealing process of the flow wrapper.Target date: (b)(6)2016.Pti replacement- bonfiglioli units will be replacing the pti units.Target date: apr2016.Process related?: yes.

Event Description

The substance inside there splashed out on his face and eyes [accidental exposure to product] the substance inside there splashed out on his face and eyes [exposure via eye contact] the substance inside there splashed out on his face and eyes [device leakage] case description: this is a spontaneous report from a contactable consumer for his son.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number m59543, expiration date sep2018, from an unspecified date for an unspecified indication.The patient medical history was not reported.There were no concomitant medications.The reporter mentioned that he purchased 3 boxes of thermacare heat wrap back pain therapy of lower back and hip and last night ((b)(6) 2016) his son went to open the pack up and when he did, the substance inside there splashed out on his face and eyes and because they did not know what was in there , they called poison control line to inquire and he also tried pfizer drug safety but he could not get through and he never had this happened before and then in next pack and that was already partially opened and it appeared like it was activated, it was deflated and it did not look like normal.The reporter mentioned that he already put his son's head under the sink and put the water in his eyes and his eyes were not turning red or anything so flushed out whatever substance it got in there.He bought the eye solution to flush his eyes out.The reporter mentioned that his son was exposed around 8.45pm and at 9.12pm he was buying the eye solution.The action taken of the product and the outcome of the event was unknown.Investigation summary received from product quality complaint included: subclass: cells damaged/leaking.Investigation summary: our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The alleged defective sample have not been received at the site, nor has the requested photographs of alleged defective wrap been attached in pcom.The complaint cannot be confirmed.Review of records does not provide any evidence of defective product.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.Additional information received from the product quality complaint group reported: investigation summary: all in process procedures were followed, and all release criteria met, however, there is the potential for this defect to occur.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Most likely root cause: process defect; an insufficient pouch seal.Pouch sealing defects are being trended for all batches.If a trend is identified for a specific batch further investigation will be conducted.There are two projects in process to decrease/eliminate unsealed or leaking pouches: pouch sealing- engilico equipment- will be added to the flow rapper.It will measure the sealing process of the flow wrapper.Target date: (b)(6)2016.Pti replacement- bonfiglioli units will be replacing the pti units.Target date: (b)(6) 2016.Process related?: yes.Follow-up (14mar2016): new information reported from product quality complaint included: investigation summary.Follow up (28mar2016): new information received from the product quality complaints group included investigational results.Follow-up (28apr2016): follow-up attempts are completed.No further information is expected.Follow-up (15feb2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "he substance inside there splashed out on his face and eyes " (device leakage) and (accidental exposure to product),(exposure via eye) were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device.

• 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
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9263823
• MDR Text Key: 220275926
• Report Number: 1066015-2019-00357
• 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: 02/15/2016

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
• Device Expiration Date: 09/01/2018
• Device Lot Number: M59543
• Initial Date Manufacturer Received: 02/15/2016
• 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 Age: 19 YR
• Patient Weight: 74