MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-11 for DOLI S * manufactured by Dornier Medical Systems, Inc..
[21392219]
A total of 36 pts were evaluated with ultrasound before and after eswl with the doli s machine. Subcapsular hematoma resulted in 4 kidneys of 4 pts for an incidence of 15%. Findings of 15% occurrence of perirenal hematoma is above the accepted 0. 2-0. 4% commonly noted with other lithotripters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021616 |
| MDR Report Key | 326968 |
| Date Received | 2001-04-11 |
| Date of Report | 2001-03-30 |
| Date Added to Maude | 2001-04-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOLI S |
| Generic Name | LITHOTRIPTER |
| Product Code | NCV |
| Date Received | 2001-04-11 |
| Model Number | DOLI S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 316375 |
| Manufacturer | DORNIER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1155 ROBERTS BLVD KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-11 |