MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for COMPACT DELTA II K1026730 manufactured by Dornier Medtech Systems Gmbh.
[174167449]
A service report completed 12 december 2019 by a dmta field service engineer concluded that the device was operating within dornier specifications. A hematoma is listed as a potential adverse effect and complication in the compact delta ii operating manual. The details concerning individual patient outcome are not known beyond treatment for the noted hematoma. No defects or inconsistencies were noted with the device as manufactured. No fault was identified with the device during this investigation.
Patient Sequence No: 1, Text Type: N, H10
[174167450]
Patient hematoma reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2019-00060 |
| MDR Report Key | 9565160 |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-10 |
| Date Facility Aware | 2019-12-10 |
| Report Date | 2020-01-08 |
| Date Reported to Mfgr | 2020-01-08 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT DELTA II |
| Generic Name | LITHOTRIPTER |
| Product Code | LNS |
| Date Received | 2020-01-08 |
| Model Number | COMPACT DELTA II |
| Catalog Number | K1026730 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING, D-82234 GM D-82234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |