MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-11-26 for ACE HALO SYSTEM 1374 manufactured by Depuy Acromed, Inc..
[251396]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2002-00074 |
| MDR Report Key | 430048 |
| Report Source | 07 |
| Date Received | 2002-11-26 |
| Date of Report | 2002-11-26 |
| Date Mfgr Received | 2002-11-14 |
| Date Added to Maude | 2002-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE HALO SYSTEM |
| Generic Name | UNIVERSAL TONG |
| Product Code | HAX |
| Date Received | 2002-11-26 |
| Model Number | NA |
| Catalog Number | 1374 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 419037 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
| Baseline Brand Name | ACE UNIVERSAL TONG KIT |
| Baseline Generic Name | HALO, TONGS, PINS |
| Baseline Catalog No | 1374 |
| Baseline Device Family | ACE HALO SYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954069 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-11-26 |