MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-20 for SHARKS/S-LINE 4622.1313 manufactured by Richard Wolf Gmbh.
| Report Number | 1418479-2019-00047 |
| MDR Report Key | 9100884 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-07-17 |
| Date Facility Aware | 2019-08-22 |
| Report Date | 2019-09-20 |
| Date Reported to FDA | 2019-09-20 |
| Date Reported to Mfgr | 2019-09-20 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2018-11-02 |
| Date Added to Maude | 2019-09-20 |
| 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 MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARKS/S-LINE |
| Generic Name | CUTTING ELECTRODE BIPO 24FR 12/30? |
| Product Code | JOS |
| Date Received | 2019-09-20 |
| Model Number | 4622.1313 |
| Catalog Number | 4622.1313 |
| Lot Number | 51015519 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-09-20 |