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

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

Patient Problems Scar Tissue (2060); Tissue Damage (2104)

Event Type  Injury  

Event Description

Patient's skin slightly came off when they removed the nsw patch [skin exfoliation] , left a slight scar [scar].Case narrative: this is a spontaneous report from a non-contactable consumer via a sales representative.A (b)(6) male patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at an unspecified frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient's skin slightly came off when they removed the nsw patch and left a slight scar on an unspecified date.The action taken with the product in response to the events and the events' outcome were unknown.No follow-up attempts are possible.No further information is expected.Follow-up (16sep2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Company clinical evaluation comment: based on the information provided, the events skin exfoliation and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events skin exfoliation and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

• 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: 9259834
• MDR Text Key: 182469312
• Report Number: 1066015-2019-00296
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2017

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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 Age: 40 YR