MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-23 for SLIMLINE EZ manufactured by Slimline Ez.
[977533]
Device used to retrieve (left) kidney stone called 200 laser - slimline ez, broke into 2 pieces during procedure - both pieces retrieved from the pt immediately - no permanent harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008732 |
| MDR Report Key | 1210883 |
| Date Received | 2008-10-23 |
| Date of Report | 2008-10-23 |
| Date of Event | 2008-10-15 |
| Date Added to Maude | 2008-11-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLIMLINE EZ |
| Generic Name | DEVICE USED FOR KIDNEY STONES |
| Product Code | LNK |
| Date Received | 2008-10-23 |
| Returned To Mfg | 2008-10-15 |
| Lot Number | 78260708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1262347 |
| Manufacturer | SLIMLINE EZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-23 |