MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-11-04 for AQUASONIC 100 ULTRASOUND TRANSMISSION GEL * 0341-01-08 manufactured by Parker Laboratories, Inc..
[16472402]
Squeeze bottle ruptured allowing heated gel to squirt out on pt. Potential for burn injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2212018-1996-00001 |
| MDR Report Key | 47525 |
| Report Source | 06 |
| Date Received | 1996-11-04 |
| Date of Report | 1996-10-07 |
| Date of Event | 1996-09-04 |
| Date Mfgr Received | 1996-10-09 |
| Date Added to Maude | 1996-11-12 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | AQUASONIC 100 ULTRASOUND TRANSMISSION GEL |
| Generic Name | DISPENSER FOR ULTRASOUND TRANSMISSION GEL |
| Product Code | KNG |
| Date Received | 1996-11-04 |
| Model Number | * |
| Catalog Number | 0341-01-08 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 48322 |
| Manufacturer | PARKER LABORATORIES, INC. |
| Manufacturer Address | 307 WASHINGTON ST ORANGE NJ 07050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-04 |