MAUDE Adverse Event Report: 3M HEALTHCARE BAIR HUGGER PATIENT WARMER

Device Problem Insufficient Information (3190)

Patient Problems Disability (2371); Post Operative Wound Infection (2446); Ambulation Difficulties (2544); Test Result (2695)

Event Date 06/24/2014

Event Type  Injury  

Event Description

The bair hugger patient warmer was used during my hip replacement surgery on (b)(6) 2014.I developed a postoperative infection with corneybacterium, had an exchange/washout procedure in (b)(6) 2014.The infection reoccurred.Had an antibiotic loaded spacer placed (b)(6) 2015.I will be having another surgery in about six weeks.It will either be a new antibiotic loaded spacer of a new hip prosthesis and hip revision.I am wheelchair bound and have been deathly ill for over a year.At this point, i do not know if i will ever walk again.The bair hugger warmer has been used on me with each of the three surgeries i have already had.Please take this warmer off the market before it injures someone else!.

• Brand Name: BAIR HUGGER PATIENT WARMER
• Type of Device: BAIR HUGGER PATIENT WARMER
• Manufacturer (Section D): 3M HEALTHCARE
• MDR Report Key: 5113830
• MDR Text Key: 27189795
• Report Number: MW5056637
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Other Device ID Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 98