MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-02-08 for AQUASONIC 100 ULTRASOUND GEL 01-08 manufactured by Parker Laboratories, Inc..
[3136123]
Parker laboratories quality assurance department (b)(4) received a phone call from patient '(b)(6)' on (b)(6) 2013. On (b)(6) 2013, (b)(6) received a transvaginal ultrasound at (b)(6) where parker laboratories's aquasonic 100 ultrasound gel (ref 01-08) was used. Later that day (b)(6)'s husband (b)(6) developed hives and anaphylactic shock (vomiting, sweating) after intercourse with (b)(6). (b)(6) reported that (b)(6) has allergies to penicillin, strawberries and all non-steroidal anti-inflammatories. (b)(6) reported that (b)(6) had epinephrine benadryl steroids prescribed by 'ambulatory care' (b)(6) and was home and ok. On (b)(6) 2013, during a follow-up phone call by parker's (b)(6), (b)(6) confirmed again that (b)(6) was ok. On (b)(6) 2013, parker qa manager (b)(4) talked with risk manager, (b)(6). (b)(6) described u/s procedure as using a latex condom sheath on the u/s probe with aquasonic 100 gel. It is not clear if the gel was on both the inside and outside of the latex condom. (b)(6) was aware of (b)(6)'s allergic reaction but identified that the patient, (b)(6), was their concern and responsibility. (b)(6) reported that they did not intend to file a form 3500a.
Patient Sequence No: 1, Text Type: D, B5
[10441444]
Initial report received from patient on (b)(6) 2013. Hipaa confidential information recorded on complaint (b)(6) at parker laboratories. Aquasonic 100 ultrasound gel is available in five different sizes; 01-20 is a 20ml single use packette, 01-02 is a 60g tube, 01-08 is a 250 ml dispenser, 01-34 is a 1 liter bottle and 01-50 is a 5 liter container. It is unknown which size or lot number was used during this procedure and the 01-08 size was used in this report because it is a common package size.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2212018-2013-00001 |
| MDR Report Key | 2954219 |
| Report Source | 04 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-01-09 |
| Date of Event | 2013-01-07 |
| Date Mfgr Received | 2013-01-09 |
| Date Added to Maude | 2013-02-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 GEL |
| Generic Name | MUI, ULTRASOUND GEL |
| Product Code | MUI |
| Date Received | 2013-02-08 |
| Catalog Number | 01-08 |
| Lot Number | UNK |
| 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. Life Threatening | 2013-02-08 |