MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for AQUASONIC CLEAR ULTRASOUND GEL manufactured by Parker.
[101766603]
I had a transvaginal ultrasound and the radiology tech used the clear aquasonic ultrasound gel. I had a severe reaction to the blue one before and i had a much lesser but still evident reaction to this clear one. The skin irritation is an intense burning and itching the longer it's there and doesn't go away after washing it off. This reaction is very similar to my latex allergy. I'm not sure if this gel has anything in common with latex. "did the problem return if the person reduced the dose or stopped taking or using the product: no, did the problem return if the person started taking or using the product again: yes, do you still have the product in case we need to evaluate it: no. " reason for use: transvaginal ultrasound gel or tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075702 |
| MDR Report Key | 7317014 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-03-01 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AQUASONIC CLEAR ULTRASOUND GEL |
| Generic Name | AQUASONIC CLEAR ULTRASOUND GEL |
| Product Code | MUI |
| Date Received | 2018-03-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |