MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), (device lot number and expiration date was not provided) via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer reported when i opened the box to use one this evening.I found 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.Follow up (08jun2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available., comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), (device lot number and expiration date was not provided) via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported when she opened the box to use one this evening ((b)(6) 2018).She found 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over her floor.The action taken with thermacare heatwrap and the outcome of the event was unknown.According to the product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.The site investigation is in process.Follow up (08jun2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (12nov2019): new information received from the product quality complaint group includes malfunction assessment and severity rating.Company clinical evaluation comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available., comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), (device lot number and expiration date was not provided) via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported when she opened the box to use one this evening ((b)(6) 2018).She found 2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over her floor.The action taken with thermacare heatwrap and the outcome of the event was unknown.According to the product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: this investigation was conducted for an unknown lot number for menstrual 8hr product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample 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 heat cells damaged/leaking.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 and/or return sample 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 cells damaged/leaking.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: no lot number provided, no lot trending performed.Follow up (08jun2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (12nov2019): new information received from the product quality complaint group includes malfunction assessment and severity rating.Follow-up (15nov2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the reported device leakage (2 of the patches in the box were unusable, 2 of the 3 patches were defective, one was actually caught in the sealed seam of the package and ripped, releasing the charcoal all over my floor) has been identified prior to use of the device.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number for menstrual 8hr product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample 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 heat cells damaged/leaking.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 and/or return sample 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 cells damaged/leaking.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: no lot number provided, no lot trending performed.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9260327
• MDR Text Key: 220260070
• Report Number: 1066015-2019-00352
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2019; 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1