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

Lot Number L72538

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 08/12/2015

Event Type  Injury  

Event Description

Burn blisters all over my lower abdomen [burns second degree], some of the burn blisters had already ruptured [blister rupture].Case description: this is a spontaneous report from a contactable consumer.This is a report received from the us fda.The regulatory authority report number is mw5055608.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to receive thermacare heatwrap (thermacare menstrual) (lot #: l72538) from an unspecified date for an unspecified indication.The patient's medical history was not reported.Concomitant medication included trazodone (trazodone), citalopram (citalopram), ibuprofen (ibuprofen) and mepyramine maleate, pamabrom, paracetamol (pamprin) all from unspecified dates and all for unspecified indications.On (b)(6) 2015, the patient reported using the heatwrap for 3 hours and felt pain in their abdomen.The patient moved the heatwrap down and noticed burn blisters all over their abdomen.The patient stated some of these blisters had already ruptured.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 based on the information provided, the events burns second degree and blister rupture as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree and blister rupture as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.A corrective action procedure for individual cell temperature was completed for run day three.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps met the required specification for thermal temperature.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature required specification.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.Quality assurance report (b)(4) (manufacturing investigation) determined method/procedure as the root cause.Production of thermacare wraps with hot cells is a known, non-conformance; as these defects can randomly occur due to manufacturing process variability.The root cause is considered a common cause due to process variability.Process related: no design related: no complaint confirmed: no.

Event Description

Case description: this is a spontaneous report from a contactable consumer.This is a report received from the us fda.The regulatory authority report number is mw5055608.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to receive thermacare heatwrap (thermacare menstrual) (lot #: l72538 expiration date: may2018) from an unspecified date for an unspecified indication.The patient's medical history was not reported.Concomitant medication included trazodone, citalopram, ibuprofen and mepyramine maleate, pamabrom, paracetamol (pamprin), all from unspecified dates and for unspecified indications.On (b)(6) 2015, the patient reported using the heatwrap for 3 hours and felt pain in their abdomen.The patient moved the heatwrap down and noticed burn blisters all over their abdomen.The patient stated some of these blisters had already ruptured.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.New information reported from product quality complaints on 10dec2015, investigation summary included: the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.A corrective action procedure for individual cell temperature was completed for run day three.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps met the required specification for thermal temperature.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature required specification.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.Quality assurance report (b)(4).(manufacturing investigation) determined method/procedure as the root cause.Production of thermacare wraps with hot cells is a known, non-conformance; as these defects can randomly occur due to manufacturing process variability.The root cause is considered a common cause due to process variability.Process related: no design related: no; complaint confirmed: no.Additional information has been requested and will be provided as it becomes available.Follow-up (10dec2015): new information reported from product quality complaints included: investigation conclusion.Company clinical evaluation comment based on the information provided, the events burns second degree and blister rupture as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree and blister rupture as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.A corrective action procedure for individual cell temperature was completed for run day three.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps met the required specification for thermal temperature.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature required specification.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.Quality assurance report (b)(4).(manufacturing investigation) determined method/procedure as the root cause.Production of thermacare wraps with hot cells is a known, non-conformance; as these defects can randomly occur due to manufacturing process variability.The root cause is considered a common cause due to process variability.Process related: no design related: no complaint confirmed: no.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5180871
• MDR Text Key: 29410203
• Report Number: 1066015-2015-00139
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2018
• Device Lot Number: L72538
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention