MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for HULKA-KENWICK UTERINE ELEVAT FCPS273MM EO422R manufactured by Contract Manufacturer: Avalign German Instruments.
[122157844]
Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[122157845]
During a gynecological procedure, a uterine elevator was clamped on the patient and fell off. There was no patient injury reported, no surgical delay. No additional intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00023 |
| MDR Report Key | 7916112 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-05 |
| Date Facility Aware | 2018-09-05 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-09-27 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS |
| Manufacturer Street | 626 COOPER COURT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HULKA-KENWICK UTERINE ELEVAT FCPS273MM |
| Generic Name | UTERINE ELEVATOR |
| Product Code | HGC |
| Date Received | 2018-09-27 |
| Model Number | EO422R |
| Catalog Number | EO422R |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS |
| Manufacturer Address | 626 COOPER COURT SHAUMBURG IL 60173 US 60173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |