MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number M32788

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges the wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Complaint confirmed: no.

Event Description

One heat wrap of a 6ct pack was reported as too hot [device issue] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip), device lot number: m32788, expiration date: aug2018, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported "one heat wrap of a 6ct pack was too hot" on an unspecified date.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.Product quality complaint group provided investigation summary on (b)(6) 2019 as follows: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges the wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Complaint confirmed: no.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient reported "one heat wrap of a 6ct pack was reported as too hot." 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.No device malfunction has been identified, comment: based on the available information, the patient reported "one heat wrap of a 6ct pack was reported as too hot." 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.No device malfunction has been identified.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges the wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Complaint confirmed: no.

Event Description

Event verbatim [preferred term] one heat wrap of a 6ct pack was reported as too hot [device issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip), device lot number: m32788, expiration date: aug2018, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported "one heat wrap of a 6ct pack was too hot" on an unspecified date.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.Product quality complaint group provided investigation summary on 25oct2019 as follows: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges the wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Complaint confirmed: no.According to the product quality complaint group: severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (13nov2019): new information received from the product quality complaint group includes severity rating.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: based on the available information, the patient reported "one heat wrap of a 6ct pack was reported as too hot." 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.This case will be re-assessed should additional information becomes available.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿adhesive /hydrocolloid contaminated / dirty¿ with a potential root cause for this failure mode could be ¿material handling¿.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warnings and precautions: 1.Do not use the statlock® device where loss of adherence could occur, such as with a confused patient, diaphoretic or non-adherent skin, or when the access device is not monitored daily.2.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.3.Minimize catheter manipulation during application and removal of the statlock® device.4.Daily maintenance: a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.B.If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide.Do not use alcohol or prepackaged bathing systems, which could lead to early lifting.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per facility protocol.E.Use clinical judgment on the removal of the statlock® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

Event verbatim [preferred term] one heat wrap of a 6ct pack was reported as too hot [device issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip), device lot number: m32788, expiration date: aug2018, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported "one heat wrap of a 6ct pack was too hot" on an unspecified date.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.Product quality complaint group provided investigation summary on 25oct2019 as follows: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges the wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Complaint confirmed: no.According to the product quality complaint group: severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (13nov2019): new information received from the product quality complaint group includes severity rating.Company clinical evaluation comment: based on the available information, the patient reported "one heat wrap of a 6ct pack was reported as too hot." 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.No device malfunction has been identified.This case will be re-assessed should additional information becomes available., comment: based on the available information, the patient reported "one heat wrap of a 6ct pack was reported as too hot." 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.No device malfunction has been identified.This case will be re-assessed should additional information becomes available.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9301401
• MDR Text Key: 197594004
• Report Number: 1066015-2019-00478
• 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
• Report Date: 05/09/2017

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
• Device Expiration Date: 08/01/2018
• Device Lot Number: M32788
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2019; 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1