MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-19 for REVOLUTION CMS W/ BREAKAWAY FEMORAL NOZZLE, CEMENT APPL. KIT & PROX. MED. PRESS. 0606705000 manufactured by Stryker Instruments-puerto Rico.
[130794650]
The user facility reported that the there was small black debris found inside the bottom of a tube and in the bottom of the tray during preparation prior to a procedure. There was no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02840 |
| MDR Report Key | 8178698 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-07-10 |
| Date Added to Maude | 2018-12-19 |
| 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 | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 |
| Manufacturer City | ARROYO 00615 |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVOLUTION CMS W/ BREAKAWAY FEMORAL NOZZLE, CEMENT APPL. KIT & PROX. MED. PRESS. |
| Generic Name | MIXER, CEMENT, FOR CLINICAL USE |
| Product Code | JDZ |
| Date Received | 2018-12-19 |
| Catalog Number | 0606705000 |
| Lot Number | 18191012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-PUERTO RICO |
| Manufacturer Address | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 ARROYO 00615 00615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |