MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for XEN 45 GTS (AUSTRALIA) 5517-001 manufactured by Allergan (austin).
[188651059]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of high intraocular pressure, conjunctival hemorrhage, gel stent fracture and vision loss are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Patient Sequence No: 1, Text Type: N, H10
[188651060]
Healthcare professional reported a xen 45 gel stent patient was implanted in the left eye. Patient was npl and the xen device "appears to have broken" and the iop of the eye remains at 42 with bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00144 |
| MDR Report Key | 9880145 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (AUSTIN) |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEN 45 GTS (AUSTRALIA) |
| Generic Name | IMPLANT, EYE VALVE |
| Product Code | KYF |
| Date Received | 2020-03-25 |
| Catalog Number | 5517-001 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (AUSTIN) |
| Manufacturer Address | 12331-A RIATA TRACE PARKWAY BUILDING 3 AUSTIN TX 78727 US 78727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |