MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for SPIGGLE & THEIS PANETTI SUCTION SEPERATOR 10-808-12 manufactured by Spiggle & Theis Medizintechnik Gmbh.
| Report Number | 1926681-2019-00729 |
| MDR Report Key | 8848269 |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-05-16 |
| Date Facility Aware | 2019-07-11 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2019-07-31 |
| 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 | DR. MARTINA ZELL |
| Manufacturer Street | BURGHOF 14 |
| Manufacturer City | OVERATH, 51491 |
| Manufacturer Country | GM |
| Manufacturer Postal | 51491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPIGGLE & THEIS PANETTI SUCTION SEPERATOR |
| Generic Name | SUCTION SEPERATOR |
| Product Code | OCX |
| Date Received | 2019-07-31 |
| Returned To Mfg | 2019-06-14 |
| Model Number | 10-808-12 |
| Lot Number | 045/02-18 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIGGLE & THEIS MEDIZINTECHNIK GMBH |
| Manufacturer Address | BURGHOF 14 OVERATH, 51491 GM 51491 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-31 |