MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for OVARIAN BIOPSY SET NO. 1 16445 manufactured by Labotect Labor-technik-g?ttingen Gmbh.
| Report Number | 9617654-2018-00001 |
| MDR Report Key | 8840182 |
| Date Received | 2019-07-30 |
| Date of Report | 2017-09-04 |
| Date of Event | 2017-09-14 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2019-07-30 |
| 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. MICHAEL BRZOZOWSKI |
| Manufacturer Street | KAMPWEG 12 |
| Manufacturer City | ROSDORF, 37124 |
| Manufacturer Country | GM |
| Manufacturer Postal | 37124 |
| Manufacturer G1 | M |
| Manufacturer Street | WASSERKUPPENSTR. 29-31 |
| Manufacturer City | FULDA, 36043 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 36043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OVARIAN BIOPSY SET NO. 1 |
| Generic Name | FOLLICLE ASPIRATON SET/NEEDLE |
| Product Code | MQE |
| Date Received | 2019-07-30 |
| Catalog Number | 16445 |
| Lot Number | 800809 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABOTECT LABOR-TECHNIK-G?TTINGEN GMBH |
| Manufacturer Address | KAMPWEG 12 ROSDORF, 37124 GM 37124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-30 |