MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-28 for FERG-FRAZIER SUCT 6FR 2/110MM WRK-LGTH GF351R manufactured by Aesculap Ag.
[179470002]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[179470003]
It was reported that there was an issue with the frazier suction. It was reported that the tip of the instrument broke off during the first insertion. There was no patient harm. An additional medical intervention was not necessary. Additional information was not provided. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00864 |
| MDR Report Key | 9528475 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-28 |
| Date of Report | 2020-01-18 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2019-12-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FERG-FRAZIER SUCT 6FR 2/110MM WRK-LGTH |
| Generic Name | MICRO NEUROSURGICAL INSTR. / D |
| Product Code | GEA |
| Date Received | 2019-12-28 |
| Returned To Mfg | 2019-12-23 |
| Model Number | GF351R |
| Catalog Number | GF351R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-28 |