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

Lot Number AL8679

Device Problem Break (1069)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

Busted on the daughter [device breakage], it busted on the daughter [accidental exposure to product], , narrative: this is a spontaneous report received from a non-contactable consumer reported for daughter.A female patient of unknown age received thermacare heatwrap (thermacare menstrual) lot number al8679, expiration date dec2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history included she was disable.Concomitant medications were not reported.The reporter had the thermacare menstrual and it busted on the daughter.There wasn't anything on her skin.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 4.7 was below the upper control limit (ucl) of 25.2 complaints per million produced per sop-#, complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.Document review summary: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.There were no wrap quality defects recorded for the batch involving cell pack integrity.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available at the site for evaluation.The complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, 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 batch is not impacted by this complaint.Site sample status: not received.

Event Description

Event verbatim [preferred term] busted on the daughter [device breakage], it busted on the daughter [accidental exposure to product], , narrative: this is a spontaneous report received from a non-contactable consumer reported for daughter.A female patient of unknown age received thermacare heatwrap (thermacare menstrual) (device lot number al8679, expiration date dec2021) from an unspecified date to an unspecified date for an unspecified indication.Medical history included she was disabled.Concomitant medications were not reported.The reporter had the thermacare menstrual and it busted on the daughter.There wasn't anything on her skin.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Product investigation results are as follows: lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 4.7 was below the upper control limit (ucl) of 25.2 complaints per million produced per sop-#, complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.Document review summary: batch al8679 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.There were no wrap quality defects recorded for the batch involving cell pack integrity.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available at the site for evaluation.The complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, 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 batch is not impacted by this complaint.Site sample status: not received.Follow-up (05mar2021): new information reported from product quality complaints includes: product investigation results.No follow up attempts are possible.No further information is expected.

• 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: 11425762
• MDR Text Key: 280453087
• Report Number: 1066015-2021-00032
• 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
• Report Date: 02/26/2021

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: 12/01/2021
• Device Lot Number: AL8679
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1