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

Lot Number R23404

Device Problems Unsealed Device Packaging (1444); Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

The root cause category is equipment - flow wrapper.Evaluation of the return sample shows the pouch was not completely sealed during manufacturing.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.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec (b)(4), effective date: 21apr2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.To improve the verification of pouch integrity (name) equipment was added to the flow wrapper on 10jan2017.It measures the sealing process of the flow wrapper.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Pouch sealing defects are being trended for all batches at the site level with every complaint (by batch) using the lot history report and by the data and analysis group monthly.If a trend is identified for a specific batch, further investigation will be conducted.

Event Description

Event verbatim [preferred term] he has also used ones around his back [device use error], the cells were hard and did not heat up.The little beads were hard as a rock [device issue].Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.A (b)(6) year-old male patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: r23404, expiration date: may2019) from (b)(6) 2016 to relieve muscle tension.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2017, the patient reported he bought 4 boxes every 2 weeks, last two boxes he bought they did not work, the cells were hard and did not heat up.The little beads were hard as a rock.Normally they were soft and warm up after you put them on.He had also used ones around his back on an unspecified date.He had been using them for 3 to 4 years.Stated there was something wrong with them and hoped he just got a bad batch.Action taken for the product was unknown.No therapeutic measures were taken as a result of the events.The patient reported he was hospitalized for using neck heatwraps around his back and received unspecified treatment on (b)(6) 2017.There was no further information about the patient's hospitalization.The patient reported "fine now." clinical outcome of the event was unknown.As of (b)(6) 2017, the product quality complaint (pqc) group investigation results stated that the root cause category is equipment - flow wrapper.Evaluation of the return sample shows the pouch was not completely sealed during manufacturing.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.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec (b)(4), effective date: 21apr2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.To improve the verification of pouch integrity (name) equipment was added to the flow wrapper on (b)(6) 2017.It measures the sealing process of the flow wrapper.After a review of the leak data, the batch in question did not have any leak results outside the release specifications.Pouch sealing defects are being trended for all batches at the site level with every complaint (by batch) using the lot history report and by the data and analysis group monthly.If a trend is identified for a specific batch further investigation will be conducted.Additional information has been requested and will be provided as it becomes available.Follow-up (26may2017): new information received from a contactable consumer includes: patient details, no concomitant medications, suspect product start date, suspect product indication, no therapeutic measures taken and patient reported hospitalization.Follow-up (19jun2017): this is a follow-up spontaneous report from a contactable physician includes: this physician reported the patient did not provide information to him/her regarding the reported adverse events with the use of the product.Follow-up (23jun2017): new information reported from the pqc group includes: product investigation summary results.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up is being submitted to amend previously reported information: seriousness updated and narrative amended.Follow-up (26may2017): this follow-up report is being submitted as a serious, reportable mdr.Event onset date updated and seriousness criteria of hospitalization and intervention required selected.Company clinical evaluation comment: based on the available information, the report of "little beads were hard as a rock" & "used ones around his back" with hospitalization involved were considered serious and associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the available information, the report of "little beads were hard as a rock" & "used ones around his back" with hospitalization involved were considered serious and associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8368819
• MDR Text Key: 137133420
• Report Number: 1066015-2019-00046
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

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: 05/01/2019
• Device Lot Number: R23404
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR