MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-13 for SHEATH FOR E-LINE CYSTOSCOPE 21FR 86500.445 manufactured by Richard Wolf Gmbh.
| Report Number | 9611102-2019-00036 |
| MDR Report Key | 9583472 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-10-31 |
| Device Manufacturer Date | 2005-10-06 |
| Date Added to Maude | 2020-01-13 |
| 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 | SHEATH FOR E-LINE CYSTOSCOPE 21FR |
| Generic Name | SHEATH FOR E-LINE CYSTOSCOPE 21FR |
| Product Code | FDC |
| Date Received | 2020-01-13 |
| Model Number | 86500.445 |
| Catalog Number | 86500.445 |
| Lot Number | M577810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization | 2020-01-13 |