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

Lot Number R97319

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Necrosis (1971)

Event Date 10/14/2017

Event Type  Injury  

Event Description

After removal of thermacare a 3 x 2 cm necrosis remained - necrosis right gluteal after heating plaster [skin necrosis], applied the batch directly to the body [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer (patient) and a contactable physician.An (b)(6)-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot number r97319, expiry date dec2017, from (b)(6) 2017 to an unspecified date at unknown dose, single, and from (b)(6) 2017 to an unspecified date at unknown dose, single for back pain.Medical history included ongoing chronic venous insufficiency, ongoing xerosis cutis.He did not drink alcohol or smoke.The patient's concomitant medications were none.The patient previously took heat plasters and experienced no adverse event.He used thermacare for the first time on (b)(6) 2017 (with no problem) and for the second and last time on (b)(6) 2017 (causing a problem).On (b)(6) 2017 he used thermacare for the second time for his back.After removing the plaster a 3 x 2 cm necrosis remained in (b)(6) 2017.For some weeks he tried to remove the necrosis, however he was not successful.On (b)(6) 2018 he visited the ambulance.The outpatient department report stated visit was from the (b)(6) 2018.Diagnosis: necrosis right gluteal after heating plaster, chronic venous insufficiency, xerosis cutis.Anamnesis, status, course: patient applied a heating plaster, now a 3 x 2 cm necrosis was visible at the region.Today ((b)(6) 2018) necrosectomy done as far as possible, underneath normal findings.Therapy recommendation: flamazine crème (sulfadiazine ointment) 1 x daily, for three days afterwards, mepilex border lite, 7.5 x 7.5 cm, changing bandages all three days.The patient also provided a new outpatient report from the same dermatological department dated with 05feb2018: control: clinically the necrosis was almost healed, reduced by 70 percent, granulation tissue.The surrounding was post-inflammatorily hyperpigmentated.Treatment recommendation: mepliex border lite up to recovery, changing bandages every 2-3days.The patient still suffered from the necrosis.He did not have any problems with other heating batches so far.Thermacare lower back & hip was in a red box, according to a photo attached.He did not use up the box completely.He used it on (b)(6) 2017 and on (b)(6) 2017 for about 8 hours.The patient considered himself healthy and was currently treated for changing of the bandages at the thermacare injury site.The patient classified his skin tone as normal and denied having sensitive skin or skin diseases (no atopic dermatitis, eczema, seborrheic dermatitis, skin allergy, hives or rashes).He did not sleep and was not exercising while wearing the product, was not wearing several layers of clothing over the thermacare product or a snug waistband/belt or similar or otherwise applied pressure onto the area.He applied the batch directly to the body since (b)(6) 2017.The patient controlled the skin prior and after the use of thermacare and had read the instructions before usage.The action taken in response to the event was permanently discontinued.The outcome of "skin necrosis" was resolving.The outcome of "applied the batch directly to the body" was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (07feb2018): new information received from the same contactable consumer included: patient data (age, height, weight), suspect product data (updated tradename, lot number, expiration date, start date, frequency, indication, action taken), medical history, deny of concomitant medications, new event (applied the batch directly to the body), updated event onset date and treatment received.Follow-up (09apr2018): follow up attempts completed.No further information is expected.Follow-up (23jan2018): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Company clinical evaluation comment: based on the information provided, the events of "skin necrosis" and "intentional device misuse" described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "skin necrosis" and "intentional device misuse" described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] after removal of thermacare a 3 x 2 cm necrosis remained - necrosis right gluteal after heating plaster [skin necrosis] , after product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed in the hospital, the skin underneath had become necrotic [product adhesion issue] , applied the batch directly to the body [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer (patient) and a contactable physician.An 88-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot number r97319, expiry date dec2017, from (b)(6) 2017 to an unspecified date at unknown dose, single, and from (b)(6) 2017 to an unspecified date at unknown dose, single for back pain.Medical history included ongoing chronic venous insufficiency, ongoing xerosis cutis.He did not drink alcohol or smoke.The patient's concomitant medications were none.The patient previously took heat plasters and experienced no adverse event.He used thermacare for the first time on (b)(6) 2017 (with no problem) and for the second and last time on (b)(6) 2017 (causing a problem).On (b)(6) 2017 he used thermacare for the second time for his back.After product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed in the hospital, the skin underneath had become necrotic.After removing the plaster a 3 x 2 cm necrosis remained in (b)(6) 2017.For some weeks he tried to remove the necrosis, however he was not successful.On (b)(6) 2018 he visited the ambulance.The outpatient department report stated visit was from the (b)(6) 2018.Diagnosis: necrosis right gluteal after heating plaster, chronic venous insufficiency, xerosis cutis.Anamnesis, status, course: patient applied a heating plaster, now a 3 x 2 cm necrosis was visible at the region.Today ((b)(6) 2018) necrosectomy done as far as possible, underneath normal findings.Therapy recommendation: flamazine crème (sulfadiazine ointment) 1 x daily, for three days afterwards, mepilex border lite, 7.5 x 7.5 cm, changing bandages all three days.The patient also provided a new outpatient report from the same dermatological department dated with (b)(6) 2018: control: clinically the necrosis was almost healed, reduced by 70 percent, granulation tissue.The surrounding was post-inflammatorily hyperpigmentated.Treatment recommendation: mepliex border lite up to recovery, changing bandages every 2-3days.The patient still suffered from the necrosis.He did not have any problems with other heating batches so far.Thermacare lower back & hip was in a red box, according to a photo attached.He did not use up the box completely.He used it on (b)(6) 2017 and on (b)(6) 2017 for about 8 hours.The patient considered himself healthy and was currently treated for changing of the bandages at the thermacare injury site.The patient classified his skin tone as normal and denied having sensitive skin or skin diseases (no atopic dermatitis, eczema, seborrheic dermatitis, skin allergy, hives or rashes).He did not sleep and was not exercising while wearing the product, was not wearing several layers of clothing over the thermacare product or a snug waistband/belt or similar or otherwise applied pressure onto the area.He applied the batch directly to the body since (b)(6) 2017.The patient controlled the skin prior and after the use of thermacare and had read the instructions before usage.The action taken in response to the event was permanently discontinued.The outcome of "applied the batch directly to the body" was unknown.The outcome of other events was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (07feb2018): new information received from the same contactable consumer included: patient data (age, height, weight), suspect product data (updated tradename, lot number, expiration date, start date, frequency, indication, action taken), medical history, deny of concomitant medications, new event (applied the batch directly to the body), updated event onset date and treatment received.Follow-up (09apr2018): follow up attempts completed.No further information is expected.Follow-up (23jan2018): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up (18nov2019): new information received from product complaint group included: new event (after product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed in the hospital, the skin underneath had become necrotic).Company clinical evaluation comment: based on the information provided, the events of "skin necrosis", "product adhesion issue" and "intentional device misuse" described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "skin necrosis", "product adhesion issue" and "intentional device misuse" described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] after removal of thermacare a 3 x 2 cm necrosis remained - necrosis right gluteal after heating plaster [skin necrosis] , after product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed in the hospital, the skin underneath had become necrotic [device adhesion issue] , applied the batch directly to the body [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer (patient) and a contactable physician.An 88-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot number r97319, expiry date (b)(6) 2019 from (b)(6) 2017 and from (b)(6) 2017, for back pain.Thermacare lower back & hip was in a red box, according to a photo attached.He did not use up the box completely.He used it on (b)(6) 2017 and on (b)(6) 2017 for about 8 hours.Medical history included ongoing chronic venous insufficiency, ongoing xerosis cutis.He did not drink alcohol or smoke.Concomitant medications were none.The patient previously took heat plasters and experienced no adverse event.He used thermacare for the first time on (b)(6) 2017 (with no problem) and for the second and last time on (b)(6) 2017 (causing a problem).On (b)(6) 2017 he used thermacare for the second time for his back.After product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed it in the hospital, the skin underneath had become necrotic.After removing the plaster a 3 x 2 cm necrosis remained in dec2017.For some weeks he tried to remove the necrosis, however he was not successful.On (b)(6) 2018 he visited the ambulance.The outpatient department report stated visit was from the (b)(6) 2018.Diagnosis: necrosis right gluteal after heating plaster, chronic venous insufficiency, xerosis cutis.Anamnesis, status, course: patient applied a heating plaster, now a 3 x 2 cm necrosis was visible at the region.Today (b)(6) 2018) necrosectomy done as far as possible, underneath normal findings.Therapy recommendation: flammazine crème (sulfadiazine ointment) 1 x daily, for three days afterwards, mepilex border lite, 7.5 x 7.5 cm, changing bandages all three days.The patient also provided a new outpatient report from the same dermatological department dated with (b)(6) 2018: control: clinically the necrosis was almost healed, reduced by 70 percent, granulation tissue.The surrounding was post-inflammatorily hyperpigmentated.Treatment recommendation: mepliex border lite up to recovery, changing bandages every 2-3days.The patient still suffered from the necrosis.He did not have any problems with other heating batches so far.The patient considered himself healthy and was currently treated for changing of the bandages at the thermacare injury site.The patient classified his skin tone as normal and denied having sensitive skin or skin diseases (no atopic dermatitis, eczema, seborrheic dermatitis, skin allergy, hives or rashes).He did not sleep and was not exercising while wearing the product, was not wearing several layers of clothing over the thermacare product or a snug waistband/belt or similar or otherwise applied pressure onto the area.He applied the batch directly to the body since (b)(6) 2017.The patient controlled the skin prior and after the use of thermacare and had read the instructions before usage.The action taken in response to the event was permanently discontinued.The outcome of "applied the batch directly to the body" was unknown.The outcome of other events was resolving.Per the product quality group: batch r97319 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.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports receiving "the skin underneath had become necrotic." the cause of the consumer stating the skin underneath had become necroticis is inconclusive since review of records does not provide evidence to support 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.Site sample status: not received.Follow-up (07feb2018): new information received from the same contactable consumer included: patient data (age, height, weight), suspect product data (updated tradename, lot number, expiration date, start date, frequency, indication, action taken), medical history, deny of concomitant medications, new event (applied the batch directly to the body), updated event onset date and treatment received.Follow-up (b)(6) 2018: follow up attempts completed.No further information is expected.Follow-up (b)(6) 2018: this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up (b)(6)2019: new information received from product complaint group included: new event (after product use a part of the glue remained on the patient's skin.They tried to remove it but were unable to.In the end, they removed in the hospital, the skin underneath had become necrotic).Follow-up (b)(6) 2019: new information received from product complaint group included: investigation results and updated expiration date., comment: based on the information provided, the events of "skin necrosis", "device adhesion issue" and "intentional device misuse" described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.No device malfunction has been identified.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.

Manufacturer Narrative

Batch r97319 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.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports receiving "the skin underneath had become necrotic." the cause of the consumer stating the skin underneath had become necroticis is inconclusive since review of records does not provide evidence to support 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.Site sample status: not received.

• 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: 9257858
• MDR Text Key: 184442930
• Report Number: 1066015-2019-00298
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Lot Number: R97319
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 88 YR