MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-20 for COMPACT DELTA LITHOTRIPTER UNIT 424 * manufactured by Dornier Medtech America, Inc.
[815965]
Patient admitted for lithotripsy. Pt has a 1. 2 cm kidney stone close to the renal pelvis. The patient was advised to have an eswl. The patient was brought to the lithotripsy suite, placed on the lithotriptor table and she was given a general anesthesia. The stone was brought into the cross hairs of the monitor on both projections. The patient was then properly coupled to the lithotripsy head. A total of 2500 shocks were delivered to the stone with minimal fragmentation of the stone. At the end of the procedure, the patient was returned to the postanesthesia room in a satisfactory condition. Conclusion: minimal fragmentation of the stone by eswl. Later in recovery the patient began to have increased pain. The patient was transferred to a local hospital and it was determined that she had a hematoma on her kidney.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1025518 |
| MDR Report Key | 1025518 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-03-17 |
| Report Date | 2008-03-20 |
| Date Reported to FDA | 2008-03-20 |
| Date Added to Maude | 2008-04-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT DELTA LITHOTRIPTER UNIT 424 |
| Generic Name | LITHOTRIPTER |
| Product Code | NCV |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-03-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 991754 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC |
| Manufacturer Address | 1155 ROBERTS BLVD KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-03-20 |