MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-17 for E-LINE INTERNAL SHEATH RESECTOSCOPE REUSABLE 8655.3841 manufactured by Richard Wolf Gmbh.
| Report Number | 1418479-2019-00021 |
| MDR Report Key | 8621178 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-19 |
| Date Facility Aware | 2019-04-19 |
| Report Date | 2019-05-17 |
| Date Reported to FDA | 2019-05-17 |
| Date Reported to Mfgr | 2019-05-17 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer 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. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-LINE INTERNAL SHEATH RESECTOSCOPE REUSABLE |
| Generic Name | INTERNAL SHEATH RESECTOSCOPE REUSABLE |
| Product Code | FDC |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-04-24 |
| Model Number | 8655.3841 |
| Catalog Number | 8655.3841 |
| Lot Number | 1330043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-17 |