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 |