MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for FRAZIER SLOT SUCT TUBE ANG 12FR 140MM MF498R manufactured by Aesculap Inc.
[167323712]
Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[167323713]
It was reported that there was an issue with the frazier suction tube. During an unspecified procedure, it was noted that pieces of bone were getting stuck inside the suction tube. There was no harm to the patient nor a delay in surgery. The surgeon was able to remove the bone fragment and the operation was completed successfully. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00086 |
| MDR Report Key | 9164127 |
| Date Received | 2019-10-07 |
| Date of Report | 2019-10-07 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-10-07 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FRAZIER SLOT SUCT TUBE ANG 12FR 140MM |
| Generic Name | MICRO NEUROSURGICAL INSTR. |
| Product Code | GEA |
| Date Received | 2019-10-07 |
| Model Number | MF498R |
| Catalog Number | MF498R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-07 |