MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number MI6629

Device Problems Difficult to Remove (1528); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Injury (2348)

Event Date 04/01/2016

Event Type  Injury  

Event Description

The glue on neck wraps rips her skin off [skin injury].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) , from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported the glue on neck wraps rips her skin off on an unspecified date with outcome of unknown.The patient reported this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.The action taken for thermacare heatwrap in response to the event was permanent discontinued.Additional information has been requested and will be provided as it becomes available.Follow-up (22apr2016): new information received from the contactable consumer included: this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.Company clinical evaluation comment based on the information provided, the event 'glue on neck wraps rips her skin' as described in this case is considered a 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 event 'glue on neck wraps rips her skin' as described in this case is considered a 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.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot#: mi6629, from an unspecified date in (b)(6) 2016 once a day for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported the glue on neck wraps rips her skin off on an unspecified date in (b)(6) 2016.The patient reported this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.No admission to hospital involved, treatment received included lidocaine lotion.The action taken for thermacare heatwrap in response to the event was permanent discontinued.The outcome of the event was recovered on an unknown date.Additional information has been requested and will be provided as it becomes available.Follow-up (22apr2016): new information received from the contactable consumer included: this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.Follow-up (31may2016): new information received from the contactable consumer included: patient age, event data (lot number, onset date, treatment and outcome) and product data (start date, frequency and indication).Company clinical evaluation comment based on the information provided, the event 'glue on neck wraps rips her skin' as described in this case is considered a 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 follow-up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event 'glue on neck wraps rips her skin' as described in this case is considered a 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 follow-up 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction was no.Site sample status was not received.

Event Description

Event verbatim [preferred term], the glue on neck wraps rips her skin off [skin injury], the glue on neck wraps rips her skin off [device issue].Narrative: this is a spontaneous report from a contactable consumer.A 70-years-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot#: mi6629, from an unspecified date in (b)(6) 2016 once a day for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported the glue on neck wraps rips her skin off in (b)(6) 2016.The patient reported this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.No admission to hospital involved, treatment received included lidocaine lotion.The action taken in response to the event of thermacare heatwrap was permanent discontinued.The outcome of the events was recovered on an unknown date.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction was no.Site sample status was not received.Follow-up (22apr2016): new information received from the contactable consumer included: this complaint was only for the tape on the neck wraps.There was nothing wrong with the old tape.Follow-up (31may2016): new information received from the contactable consumer included: patient age, event data (lot number, onset date, treatment and outcome) and product data (start date, frequency and indication).Follow-up attempts are completed.No further information is expected.Follow-up (06may2020): new information was received from a product quality complaint group included investigation results.No follow up attempts possible/needed.No further information is expected.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5637780
• MDR Text Key: 44700315
• Report Number: 1066015-2016-00080
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2016

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
• Device Operator: Lay User/Patient
• Device Lot Number: MI6629
• Initial Date Manufacturer Received: 04/10/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided; 05/31/2016
• Supplement Dates FDA Received: 06/07/2016; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR