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

Lot Number W81903

Device Problems Material Discolored (1170); Leak/Splash (1354)

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

Event Date 11/20/2019

Event Type  malfunction  

Event Description

The product got opened somehow and iron leaked out, device leakage, the product got opened somehow/discoloration on the heatwrap, device issue,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) (device lot number w81903, expiration date jun2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she noticed discoloration on the heatwrap after several hours of use.She supposed the product got opened somehow and iron leaked out.Therefore, she removed the heatwrap to be on the safe side.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the patient reported "product got opened somehow/discoloration on the heatwrap" and stopped the use upon identification of the device issue.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: the patient reported "product got opened somehow/discoloration on the heatwrap" and stopped the use upon identification of the device issue.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] the product got opened somehow and iron leaked out [device leakage], the product got opened somehow/discoloration on the heatwrap [device issue].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 w81903, expiration date jun2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she noticed discoloration on the heatwrap after several hours of use.She supposed the product was opened somehow and iron leaked out.Therefore, she removed the heatwrap to be on the safe side.The action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to product quality compliant group, the severity of harm has been selected by the manufacturing site as s3.Additional information has been requested and will be provided as it becomes available.Follow-up (25nov2019): new information received from product quality complaint group via us dsu includes severity level assessment.Company clinical evaluation comment: the patient reported "product got opened somehow/discoloration on the heatwrap" and stopped the use upon identification of the device issue.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: the patient reported "product got opened somehow/discoloration on the heatwrap" and stopped the use upon identification of the device issue.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.

Manufacturer Narrative

The severity of harm has been selected by the manufacturing site as s3.Site sample status was not received.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation and 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.Investigation (b)(4) (t26691, t26693, t26686 & s68516) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.Four batches (t26691, t26693, t26886 and s68516) were reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, t26686, and s68516) per investigation (b)(4).

Event Description

Event verbatim [preferred term] the product got opened somehow and iron leaked out/ the product got opened somehow/discoloration on the heatwrap [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 w81903, expiration date jun2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she noticed discoloration on the heatwrap after several hours of use.She supposed the product was opened somehow and iron leaked out.The heat wrap was dark colored, the included cells were leaking.Therefore, she removed the heatwrap to be on the safe side.The action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to product quality compliant group, the severity of harm has been selected by the manufacturing site as s3.Site sample status was not received.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation and 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.Investigation (b)(4), t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.Four batches (t26691, t26693, t26886 and s68516) were reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, t26686, and s68516) per investigation (b)(4).Follow-up (25nov2019): new information received from product quality complaint group via us dsu includes severity level assessment.Follow-up (09jan2020): new information received from product quality complaints group includes: investigation results.The follow-up is also being submitted to amend the following previously reported information: updated events (removed "device issue")., comment: the patient reported "the product got opened somehow and iron leaked out/ the product got opened somehow/discoloration on the heatwrap" and stopped the use upon identification of the device issue.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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Manufacturer Narrative

The severity of harm has been selected by the manufacturing site as s3.Batch w81903 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on a citi search was conducted for the subclass heat cells damaged/leaking - cell damaged/leaking for menstrual products, data did not show an increase over time (24 months), refer to attachment cells damaged leaking menstrual 11-21-17 to 11-21-19.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation shows some stray chemistry present on the wrap.The cell packs are intact; no chemistry is leaking from the cells.Stray chemistry is not dosed with the brine solution and will not heat up.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.Investigation pr (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.Four batches ((b)(4)) were reviewed at aqrt and the outcome determination was to recall the four batches ((b)(4)) per investigation (b)(4).Root cause/ capa: process related was no.Final confirmation status was not confirmed.The sample was received at the site on (b)(6) 2019.Return sample evaluation: one menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.Stray chemistry is present on the wrap the cell packs are intact; there is no chemistry leaking from the cells.Stray chemistry is not dosed with brine and does not heat up.One menstrual pouch - pouch is sealed no obvious defects.(l) w81903 s (b)(6) 2021 02:43 one menstrual carton - carton is open.(l) w81903 (b)(6) 2021 02:46.

Event Description

Event verbatim [preferred term] : the product got opened somehow and iron leaked out/heat wrap was dark colored/discoloration on the heatwrap [device leakage], , 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 w81903, expiration date jun2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2019, the patient reported she noticed discoloration on the heatwrap after several hours of use.She supposed the product was opened somehow and iron leaked out.The heat wrap was dark colored, the included cells were leaking.Therefore, she removed the heatwrap to be on the safe side.The action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality compliant group, the severity of harm has been selected by the manufacturing site as s3.Batch w81903 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on a citi search was conducted for the subclass heat cells damaged/leaking - cell damaged/leaking for menstrual products, data did not show an increase over time (24 months), refer to attachment cells damaged leaking menstrual 11-21-17 to 11-21-19.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample evaluation shows some stray chemistry present on the wrap.The cell packs are intact; no chemistry is leaking from the cells.Stray chemistry is not dosed with the brine solution and will not heat up.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.Investigation pr (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.Four batches ((b)(4)) were reviewed at aqrt and the outcome determination was to recall the four batches ((b)(4)) per investigation pr-(b)(4).Root cause/ capa: process related was no.Final confirmation status was not confirmed.The sample was received at the site on (b)(6) 2019.Return sample evaluation: one menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.Stray chemistry is present on the wrap the cell packs are intact; there is no chemistry leaking from the cells.Stray chemistry is not dosed with brine and does not heat up.One menstrual pouch - pouch is sealed no obvious defects.(l) w81903 s (b)(6) 2021 02:43 one menstrual carton - carton is open.(l) w81903 (b)(6) 2021 02:46.Follow-up ( (b)(6) 2019): new information received from product quality complaint group via us dsu includes severity level assessment.Follow-up ((b)(6) 2020): new information received from product quality complaints group includes: investigation results.The follow-up is also being submitted to amend the following previously reported information: updated events (removed "device issue").Follow-up ((b)(6) 2020): new information received from the product quality complaint group includes updated investigational results.Follow-up attempts are completed.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: 9396203
• MDR Text Key: 219977345
• Report Number: 1066015-2019-00505
• 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,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Lot Number: W81903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1