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

Lot Number DE4866

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urticaria (2278)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Product: therma care lower back & hip.Device lot number: de4866.Expiration date: 31dec2022.Description of compliant: "the first wrap she used actually caused whelps on her back, then the second one did not get hot, and the third one worked fine." complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.Summary of investigation and conclusion: refer to the attachment "evaluation of complaints related to open pouches." complaint handling for open pouches: complaints received at the site in the global complaint database related open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following.Released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1-no harm to customer.Complaints related to pouch have been thorough investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase, and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1-no harm to customer.

Event Description

Event verbatim: whelps on her back [urticaria].Narrative: this is a spontaneous report from a contactable consumer (patient).A female patient over (b)(6) started to use thermacare heatwrap (thermacare lower back & hip, device batch/lot number de4866, expiration date 31dec2022, 3 count box) on an unknown date applied topically for pain in lower back.Relevant medical history and concomitant medications were none.The patient always bought thermacare heatwraps for her back, she used them for years, and she bought them for her neck.She stated the thermacare lower back & hip heatwraps helped a lot.She bought a box of 3 wraps of thermacare lower back & hip earlier this year.She took the 3 packages out of the box and got rid of the box.The first wrap she used actually caused whelps on her back in (b)(6) 2020, then the second one did not get hot in (b)(6) 2020, and the third one worked fine the day before the report time (b)(6) 2020.She stated it was weird that one did not work at all, one she got whelps from, and the other worked fine.She wore the thermacare lower back & hip heatwrap all day the day before the report time (b)(6) 2020, and it worked fine, so she then took it off and threw it out.The patient used an antibacterial cream as treatment for the whelps.She did not have the box to provide the upc number from.She only had one of the packages to provide lot number and expiration date.They were all the same lot number and expiration because they came from the same box.She stated she would not buy them again.Thermacare heatwrap was temporarily withdrawn on an unknown date (in (b)(6) 2020) in response to the event whelps on her back.As a result, the patient recovered from the event in (b)(6) 2020.The event did not recur when the product was used again.A sample of the product was not available to be returned, if requested.The packaging was sealed, and intact.On 03nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Device lot number: de4866.Expiration date: 31dec2022.Description of compliant, "the first wrap she used actually caused whelps on her back, then the second one did not get hot, and the third one worked fine." complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.Summary of investigation and conclusion: refer to the attachment "evaluation of complaints related to open pouches." complaint handling for open pouches: complaints received at the site in the global complaint database related open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too coo will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following.Released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1-no harm to customer.Complaints related to pouch have been thorough investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classes is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1-no harm to customer.No follow-up attempts are needed.No further information is expected.

• 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
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 10843023
• MDR Text Key: 216837365
• Report Number: 1066015-2020-00194
• 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
• Report Date: 10/27/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Lot Number: DE4866
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73