MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-20 for DORNIER COMPACT DELTA II K1026730 manufactured by Dornier Medtech Systems Gmbh.
[145536745]
A service report completed and dated 04/23/2019 by a dmta field service engineer indicated that the device was in compliance with 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 indicates the patient was subsequently released from treatment and is doing fine. No fault with the device as manufactured. Device was found to be functioning within dornier specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145536746]
Patient hematoma reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2019-00017 |
| MDR Report Key | 8624820 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-12 |
| Date Facility Aware | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2013-04-30 |
| Date Added to Maude | 2019-05-20 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS FELABOM |
| Manufacturer Street | 1155 ROBERTS BLVD. SUITE 100 |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146106 |
| Manufacturer G1 | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Street | ARGELSRIEDER FELD 7 |
| Manufacturer City | WESSLING, BAVARIA D-82234 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-82234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER COMPACT DELTA II |
| Generic Name | LITHOTRIPTER |
| Product Code | LNS |
| Date Received | 2019-05-20 |
| Model Number | DORNIER COMPACT DELTA II |
| Catalog Number | K1026730 |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-20 |