MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-26 for XTRATRACE BELT 1421040 manufactured by Embla Systems.
[4330118]
It was observed that a pt has red welt like mark where the xacttrace belts were on his back only. Pt went to emergency.
Patient Sequence No: 1, Text Type: D, B5
[11568187]
In compliance with our quality management system requested the client to send back the xactrabelt for evaluation. Functional and temperature tests were performed and all results indicate that the device is working within the specifications - refer to the enclosed tests report. Preliminary review of the event details revealed that pt was not wearing a shirt while using the xactrabelt. The product labeling (attached herewith) clearly instructs that the exactrabelt is intended to be worn over the nightclothes. Based on the evaluation resulted and the event information we concluded that this incident was caused by the user not following the manufacturer's instructions. The client is now informed and advised to ensure that product labeling instructions are followed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005888786-2014-00001 |
| MDR Report Key | 3723906 |
| Report Source | 06 |
| Date Received | 2014-02-26 |
| Date of Report | 2014-03-25 |
| Date of Event | 2014-02-28 |
| Date Mfgr Received | 2014-02-28 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-04-04 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANJAY MEHTA |
| Manufacturer Street | 1 HINES ROAD |
| Manufacturer City | KANATA K2K3C7 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K3C7 |
| Manufacturer Phone | 2875055 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XTRATRACE BELT |
| Generic Name | UNIVERSAL XACTTRACE |
| Product Code | MNR |
| Date Received | 2014-02-26 |
| Returned To Mfg | 2014-03-11 |
| Model Number | 1421040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMBLA SYSTEMS |
| Manufacturer Address | 1 HINES ROAD KANATA K2K3C7 CA K2K3C7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-26 |