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

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem Rash (2033)

Event Type  malfunction  

Event Description

Skin rash [rash], adhesive missing on one side of the wraps, due to this she was putting adhesive tape and that adhesive tape gave her a rash [device adhesion issue], she was putting adhesive tape and that adhesive tape gave her a rash [device use error].Case narrative: the initial case was missing the following minimum criteria: there is no indication that the patient experienced an event under thermacare neck, shoulder & wrist (product complaint only).Upon receipt of follow-up information on 04-mar-2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) udi number (b)(4), from an unspecified date for an unspecified indication.Device lot number and expiration date were not available.Medical history included bad car accident, hit by drunk driver many years ago.The patient's concomitant medications were not reported.The patient loved thermacare heatwrap, these were life saver for her.She has used them for many years.It was a 3-count box and there was adhesive missing on one side of the wraps for all three of the heatwraps.They didn't stay on.She bought a pack and for each wrap, on one of the sides the adhesive was not there.She was wondering why it was not staying on one of the sides.Due to this she was putting adhesive tape and that adhesive tape gave her a rash on an unspecified date.She clarified the thermacare heatwrap did not give her a rash it was the adhesive tape.When she opened the next 2 they also did not have adhesive.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Device was available for evaluation.Additional information has been requested and will be provided as it becomes available.Comment: based on the available information, the patient experienced adhesion issue with product use as the adhesive part was missing.Therefore, the patient used another source of adhesive tape that caused a skin rash.This suggests there was a device malfunction as if it were to recur it would likely cause or contribute to death or serious injury.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

There was reasonable suggestion of device malfunction.A sample was not received at the site.This investigation was performed for an unknown lot number neck / shoulder / wrist (nsw) 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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 adhesion / fastening defect.The manufacturing operations employ quality control procedures which includes in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Classification, sub-classification, priority, product information, justification, and the site assignment grid were reviewed, and they are accurate and appropriate.A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced adhesion issue with product use as the adhesive part was missing.Therefore, the patient used another source of adhesive tape that caused a skin rash.Review of the complaint suggests there was a device malfunction.

Event Description

Skin rash [rash].Adhesive missing on one side of the wraps, due to this she was putting adhesive tape and that adhesive tape gave her a rash [device adhesion issue], she was putting adhesive tape and that adhesive tape gave her a rash [device use error].Narrative: the initial case was missing the following minimum criteria: there is no indication that the patient experienced an event under thermacare neck, shoulder & wrist (product complaint only).Upon receipt of follow-up information on 04mar2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) udi number: (b)(4), from an unspecified date for an unspecified indication.Device lot number and expiration date were not available.Medical history included bad car accident, hit by drunk driver many years ago.The patient's concomitant medications were not reported.The patient loved thermacare heatwrap, these were life saver for her.She has used them for many years.It was a 3-count box and there was adhesive missing on one side of the wraps for all three of the heatwraps.They didn't stay on.She bought a pack and for each wrap, on one of the sides the adhesive was not there.She was wondering why it was not staying on one of the sides.Due to this she was putting adhesive tape and that adhesive tape gave her a rash on an unspecified date.She clarified the thermacare heatwrap did not give her a rash it was the adhesive tape.When she opened the next 2 they also did not have adhesive.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Device was available for evaluation.Packaging was sealed and intact.Product quality complaints provided the following investigation information: there was reasonable suggestion of device malfunction.A sample was not received at the site.This investigation was performed for an unknown lot number neck / shoulder/wrist (nsw) 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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 adhesion / fastening defect.The manufacturing operations employ quality control procedures which includes in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Classification, sub-classification, priority, product information, justification, and the site assignment grid were reviewed, and they are accurate and appropriate.A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced adhesion issue with product use as the adhesive part was missing.Therefore, the patient used another source of adhesive tape that caused a skin rash.Review of the complaint suggests there was a device malfunction.Follow-up (06may2020): new information from product quality complaints includes investigation results.No follow-up attempts are needed.No further information is expected., comment: based on the available information, the patient experienced adhesion issue with product use as the adhesive part was missing.Therefore, the patient used another source of adhesive tape that caused a skin rash.This suggests there was a device malfunction as if it were to recur it would likely cause or contribute to death or serious injury.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

• 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: 9913893
• MDR Text Key: 188251281
• Report Number: 1066015-2020-00092
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 305733015025
• 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
• Report Date: 03/04/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1