MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-17 for UNKNOWN_CMF_PRODUCT UNK_CMF manufactured by Stryker Orthopaedics-limerick.
[70252338]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Cement remains in the patient.
Patient Sequence No: 1, Text Type: N, H10
[70252339]
It was reported by a physician that a patient was showing symptoms of inflammation of the eyes at a post operative follow up appointment.
Patient Sequence No: 1, Text Type: D, B5
[110484897]
According to the information received from the customer ((b)(6) 2017) the complained hydroset was not related to the reported event. It was stated that the reported event of swollen eyes was caused by a reaction to the anti-hematoma ointment. Therefore this pi is considered as inquiry and closed as phase 1.
Patient Sequence No: 1, Text Type: N, H10
[110484898]
It was reported by a physician that a patient was showing symptoms of inflammation of the eyes at a post operative follow up appointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00054 |
| MDR Report Key | 6414586 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-17 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-01-15 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-17 |
| 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. HANS GEIGER |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_CMF_PRODUCT |
| Generic Name | HA CEMENT |
| Product Code | GXP |
| Date Received | 2017-03-17 |
| Catalog Number | UNK_CMF |
| 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 ORTHOPAEDICS-LIMERICK |
| Manufacturer Address | RAHEEN BUSINESS PARK LIMERICK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-17 |