MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-30 for MEDICHOICE ULTRASOUND GEL N/A 40678OZUSGEL manufactured by Owens & Minor Distribution, Inc..
[4973314]
Patient went for ultrasound of his heart today. Complained of chest bothering him during the procedure. Told the tech and then told his wife upon his return back to his room. Per wife, it looks like two big blisters on his chest and that the skin is pushed to the side; open wound. States that when he told the tech it was sharp, she said that other patients have complained of the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4226708 |
| MDR Report Key | 4226708 |
| Date Received | 2014-10-30 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-07-08 |
| Report Date | 2014-10-29 |
| Date Reported to FDA | 2014-10-30 |
| Date Reported to Mfgr | 2014-11-05 |
| Date Added to Maude | 2014-11-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE ULTRASOUND GEL |
| Generic Name | MEDIA,COUPLING,ULTRASOUND |
| Product Code | MUI |
| Date Received | 2014-10-30 |
| Model Number | N/A |
| Catalog Number | 40678OZUSGEL |
| Lot Number | 140302 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD. MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-30 |