FDA Adverse Event
Other
Summary report: N
ACE HALO SYSTEM
MDR report key: 430048
·
Received November 26, 2002
Report
- Report Number
- 1526439-2002-00074
- Event Type
- Other
- Date Received
- November 26, 2002
- Report Date
- November 26, 2002
- Manufacturer
- DEPUY ACROMED, INC.
- Product Code
- HAX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED THAT A PATIENT WEARING A UNIVERSAL TONG DURING A MRI SCAN, COMPLAINED ABOUT PAIN AND BURNING AROUND THEIR HEAD. THE SCAN WAS STOPPED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION REVEALED THAT THE HOSPITAL RECENTLY UPGRADED THE MRI COMPUTER SYSTEM WHICH CAUSED IT TO BE MORE POWERFUL THAN WHAT THE TONG WAS DESIGNED TO WITHSTAND. A COMPLAINT HISTORY ANALYSIS WAS PERFORMED AND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PART NUMBER. THE PART WAS NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACE HALO SYSTEM | UNIVERSAL TONG | HAX | DEPUY ACROMED, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |