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

Lot Number	CW9498
Medical Device Problem Codes	Use of Device Problem (1670); Excessive Heating (4030)
Health Effect - Clinical Codes	Pain (1994); Partial thickness (Second Degree) Burn (2694)
Date of Event	09/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Burn/the burn is under her belly button on her lower abdomen/blistered up [burns second degree], it hurts now, but it didn't before [pain], did not check skin under the product while wearing it/attached the adhesive part to shorts [intentional device misuse].Narrative: this is a spontaneous report from a contactable consumer (patient).An (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) 8 hr.(device lot number cw9498, expiration date dec2022, ndc number: (b)(4)), on (b)(6) 2020 'just that day' for menstrual pain.Medical history included eczema and sensitive skin from an unknown date.There were no concomitant medications.Consumer has not previously used thermacare.The patient took it off 5 hours in, and woke up eight hours later and then noticed a burn.The burn is under her belly button on her lower abdomen on (b)(6) 2020.She is all blistered up.It hurts now, but it didn't before.She is unable to wear pants or anything against it because it rubs.She did read the instruction but did not check skin under the product while wearing it.She was wearing several layers of clothing over the thermacare product.She was 'wearing long shorts attached to that and a tank top which was compressing against the tank top'.She attached the adhesive part to shorts.Therapeutic measures include using an antibiotic cream.She has doctor's appointment tomorrow ((b)(6) 2020).She is not currently under the care of a physician for any medical condition.The patient did not previously use other heat products for pain relief (such as electric heating pad, hot water bottle or microwave gel pack).She was not sleeping while wearing the heatwrap.The patient did not engage in exercise while using the product.She was not taking any medications, including over the counter, herbal, nutritional or any applied to the skin during the time of heatwrap use.The color of the box she purchased was red.Product count size dispensed was a box of 3 and there are 2 thermacare heatwrap remaining.The packaging was sealed and intact.A sample of the product is available to be returned.Action taken with the suspect product was permanently withdrawn on (b)(6) 2020.Clinical outcome of the event burn blister and pain was not resolved.Clinical outcome of remaining event was unknown.Additional information has been requested and will be provided as it becomes available.
Event or Problem Description
Did not check skin under the product while wearing it / wearing long shorts attached to that and a tank top which was compressing against the tank top [intentional device misuse], burn / the burn is under her belly button on her lower abdomen / blistered up / it hurts [burns second degree].Narrative: this is a spontaneous report from a contactable consumer (patient).An 18-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number: cw9498, expiration date: dec2022, ndc number: 305733020029, date of manufacture:18jan2020 to 25jan2020), on (b)(6) 2020 'just that day' for menstrual pain.Medical history included eczema and sensitive skin from an unknown date.There were no concomitant medications.The patient had not previously used thermacare.The patient took it off 5 hours in, and woke up eight hours later and then noticed a burn.The burn was under her belly button on her lower abdomen on (b)(6) 2020.She was all blistered up.It hurt now, but it didn't before.She was unable to wear pants or anything against it because it rubs.She did read the instruction but did not check skin under the product while wearing it.She was wearing several layers of clothing over the thermacare product.She was wearing long shorts attached to that and a tank top which was compressing against the tank top.She attached the adhesive part to shorts.Therapeutic measures included using an antibiotic cream.She had doctor's appointment tomorrow (on (b)(6) 2020).She was not currently under the care of a physician for any medical condition.The patient did not previously use other heat products for pain relief (such as electric heating pad, hot water bottle or microwave gel pack).She was not sleeping while wearing the heatwrap.The patient did not engage in exercise while using the product.She was not taking any medications, including over the counter, herbal, nutritional or any applied to the skin during the time of heatwrap use.The color of the box she purchased was red.Product count size dispensed was a box of 3 and there were 2 thermacare heatwrap remaining.The packaging was sealed and intact.A sample of the product was available to be returned.Action taken with the suspect product was permanently withdrawn on 20sep2020.Clinical outcome of the event burn / the burn is under her belly button on her lower abdomen / blistered up / it hurt was not resolved.Clinical outcome of remaining event was unknown.According to the product quality complaint group: batch: cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event / negligible-minor received at the albany site requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event / negligible-minor for menstrual 8hr heat wrap products.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint can not be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she woke up with a burn, after using thermacare heat wrap for 5 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a 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 this batch from a manufacturing perspective.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.Root cause / capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.Follow-up (01oct2020): follow-up attempts are completed.No further information is expected.Follow-up (05oct2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.
Additional Manufacturer Narrative
Batch: cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event / negligible-minor received at the albany site requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event / negligible-minor for menstrual 8hr heat wrap products.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint can not be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she woke up with a burn, after using thermacare heat wrap for 5 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a 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 this batch from a manufacturing perspective.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.Root cause / capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.

• Brand Name: THERMACARE MENSTRUAL
• Common Device Name: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10606076
• Report Number: 1066015-2020-00170
• Device Sequence Number: 16815118
• Product Code: IMD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Lot Number: CW9498
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 61