MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-31 for #12 FRAZIER SUCTION DEVICE 285-456 manufactured by Integra Jarit.
[71725664]
Surgeon was using a 12 french frazier suction. States a sharp point at the tip of the suction punctured the dura, causing a dural tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068861 |
| MDR Report Key | 6456321 |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-03-29 |
| Date Added to Maude | 2017-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | #12 FRAZIER SUCTION DEVICE |
| Generic Name | APPARATUS, SUCTION |
| Product Code | JZF |
| Date Received | 2017-03-31 |
| Model Number | 285-456 |
| Device Expiration Date | 2017-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA JARIT |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-31 |