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

Lot Number S23900

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The wrap was not returned for evaluation by the site, the complaint can not be confirmed.Our 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.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.There was an issue mentioned in the shiftily production transition involving the material slitter on gawa #1.If the stretch material (tredegar stretch s-xl 277mm) is mis tracked there is a potential that the ultra sonic bond site could prematurely come apart during use.However without the wrap for evaluation it can not be determined if the material was mis tracked.

Event Description

Wrap bulges and leaks like it going tear and if he bends, the wrap tears device leakage, gets 60% relief device ineffective.Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old male patient started to use thermacare heatwrap (robax lower back & hip heatwrap), device lot number s23900, expiration date 29feb2020, from an unspecified date and ongoing at an unknown frequency for severe back, hip, muscles pain.The patient medical history was not reported.The patient's concomitant medications included ibuprofen/methocarbamol (robax) from 2016 and ongoing at one 1/2 - 2 pills.The patient reported this was the 4th wrap he had used, and after 1 hr.Of use the wrap bulges and leaks like it going tear and if he bends, the wrap tears.He stated he wore a t-shirt under the wrap and did not have it too tight because if it is too tight it kills you, and that he got 60% relief from the product on an unspecified date.The patient received no treatment and not admitted to hospital due to the event got only 60% relief.It was also reported that "this was a good product, maybe make extra strong and reg.And use vaseline lotion to soothing and help relief burn".The action taken in response to the events for thermacare heatwrap was unknown.The outcome both events was resolved.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The wrap was not returned for evaluation by the site, the complaint can not be confirmed.Our 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.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.There was an issue mentioned in the shiftly production transition involving the material slitter on gawa #1.If the stretch material (tredegar stretch s-xl 277mm) is mis tracked there is a potential that the ultra sonic bond site could prematurely come apart during use.However without the wrap for evaluation it can not be determined if the material was mis tracked.Follow up(29jun2017): new information received from product quality complaint group included: investigation results.Follow-up ((b)(6) 2018): new information received from the same contactable consumer includes: product indication, concomitant drugs and event data (the patient received no treatment and not admitted to hospital).Follow-up (17aug2018): follow-up attempts completed.No further information is expected.Follow-up (16may2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the events "the wrap bulges and leaks like it's going to tear" (device leakage) and device ineffective were assessed as non-serious.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device., comment: the events "the wrap bulges and leaks like it's going to tear" (device leakage) and device ineffective were assessed as non-serious.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The wrap was not returned for evaluation by the site, the complaint can not be confirmed.Our 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.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.There was an issue mentioned in the shiftly production transition involving the material slitter on gawa #1.If the stretch material (tredegar stretch s-xl 277mm) is mis tracked there is a potential that the ultra sonic bond site could prematurely come apart during use.However without the wrap for evaluation it can not be determined if the material was mis tracked.

Event Description

Event verbatim [preferred term] burn [thermal burn] , wrap bulges and leaks like it going tear and if he bends, the wrap tears [device leakage] , gets 60% relief [device ineffective].Case narrative:this is a spontaneous report from a contactable consumer.A 59-year-old male patient started to use thermacare heatwrap (robax lower back & hip heatwrap), device lot number s23900, expiration date 29feb2020, from an unspecified date and ongoing at an unknown frequency for severe back, hip, muscles pain.The patient medical history was not reported.The patient's concomitant medications included ibuprofen/methocarbamol (robax) from 2016 and ongoing at one 1/2 - 2 pills.The patient reported this was the 4th wrap he had used, and after 1 hr.Of use the wrap bulges and leaks like it going tear and if he bends, the wrap tears.He stated he wore a t-shirt under the wrap and did not have it too tight because if it is too tight it kills you, and that he got 60% relief from the product on an unspecified date.The patient received no treatment and not admitted to hospital due to the event got only 60% relief.It was also reported that "this was a good product, maybe make extra strong and reg.And use vaseline lotion to soothing and help relief burn".The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event burn was unknown.The outcome of other events was resolved.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The wrap was not returned for evaluation by the site, the complaint can not be confirmed.Our 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.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.There was an issue mentioned in the shiftly production transition involving the material slitter on gawa #1.If the stretch material (tredegar stretch s-xl 277mm) is mis tracked there is a potential that the ultra sonic bond site could prematurely come apart during use.However without the wrap for evaluation it can not be determined if the material was mis tracked.Follow up(29jun2017): new information received from product quality complaint group included: investigation results.Follow-up (05feb2018): new information received from the same contactable consumer includes: product indication, concomitant drugs and event data (the patient received no treatment and not admitted to hospital).Follow-up (17aug2018): follow-up attempts completed.No further information is expected.Follow-up (16may2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: event "burn" was added., comment: based on the information provided, the events of "burn" and "device leakage" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device ineffective" is non-serious.The events are medically assessed as associated with the use of the device.The root cause category is non-assignable (complaint not confirmed).No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Without the wrap for evaluation it can not be determined if the material was mis tracked.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257627
• MDR Text Key: 220245077
• Report Number: 1066015-2019-00322
• 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
• Report Date: 05/16/2017

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 Expiration Date: 02/29/2020
• Device Lot Number: S23900
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROBAX; ROBAX
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR