MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC GENTHERM NORM -O-TEMP; PACK, HOT OR COLD, WATER CIRCULATING

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

Patient Problems Erythema (1840); Laceration(s) (1946); Pain (1994); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 08/13/2021

Event Type  Injury  

Event Description

This patient underwent a 5 hour nasal surgery (supine position).Surgery was uneventful and he was discharged home.Patient called reporting having progressively worsening left buttock pain and swelling.Patient had some minor pain in his left gluteal region and buttock after his surgery.There was a fairly well demarcated area of redness.Patient called the next morning as the swelling and pain worsened, and there was concern for a gluteal compartment syndrome.Patient presented to the er.Patient's creatinine kinase was significantly elevated at 9405 and ct imaging showed findings consistent with a gluteal compression syndrome.General surgery took the patient to the operating room in the evening to open the left buttock and placed a wound vac.The patient will then be returning to the operating room again two days later.

• Brand Name: GENTHERM NORM -O-TEMP
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 13141729
• MDR Text Key: 283087684
• Report Number: 13141729
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2021,09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7665 DA
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White