MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-10-02 for AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 01-02 manufactured by Parker Laboratories, Inc..
[19207262]
Pt reported to fda through the medwatch program that on two separate occasions, a severe angioedema reaction occurred after ultrasound procedures using aquasonic 100, requiring oral steroids, inhaled steroids, nebulized albuterol, and h1 and h2 antihistamines. Pt is allergic to methylparaben and believes that ingredients should have been listed on the label.
Patient Sequence No: 1, Text Type: D, B5
[19423220]
Add'l catalog#'s 01-08, 01-50. Voluntary medwatch report rec'd from fda on 09/21/09. Event date indicated was 2005. No report had been rec'd at that time by the mfr. Only one other report of a similar nature has been rec'd in over five years. The pt has a known allergy to methylparaben. The identification of the preservatives in aquasonic 100 is documented on the product technical data sheet that is readily available upon request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2212018-2009-00001 |
| MDR Report Key | 1507908 |
| Report Source | 00 |
| Date Received | 2009-10-02 |
| Date of Report | 2009-09-21 |
| Date of Event | 2005-01-01 |
| Date Mfgr Received | 2009-09-21 |
| Date Added to Maude | 2009-10-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY HOHENSEE, MGR. |
| Manufacturer Street | 286 ELDRIDGE RD. |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal | 07004 |
| Manufacturer Phone | 9732769500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUASONIC 100 ULTRASOUND TRANSMISSION GEL |
| Generic Name | ULTRASOUND COUPLING MEDIA |
| Product Code | MUI |
| Date Received | 2009-10-02 |
| Model Number | NA |
| Catalog Number | 01-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKER LABORATORIES, INC. |
| Manufacturer Address | 286 ELDRIDGE RD. FAIRFIELD NJ 07004 US 07004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-02 |