MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-27 for MIXEVAC III 0206015000 manufactured by Stryker Instruments-puerto Rico.
[101168519]
The user facility reported that there were tiny bugs in the packaging found when the package was received. There was no patient impact, no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-00460 |
| MDR Report Key | 7299592 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-27 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2017-12-30 |
| Date Added to Maude | 2018-02-27 |
| 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 | MR. ZACHARY 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 | MIXEVAC III |
| Generic Name | MIXER, CEMENT, FOR CLINICAL USE |
| Product Code | JDZ |
| Date Received | 2018-02-27 |
| Returned To Mfg | 2018-03-08 |
| Catalog Number | 0206015000 |
| Lot Number | 17364012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-27 |