MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for MALYUGIN RING SYSTEM MAL-1001-1 manufactured by Microsurgical Technology.
[142461084]
Customer indicated that a patient is suspected of having endophthalmitis and was contacting all device manufacturers involved in the surgery. The malyugin ring is not suspected to have caused the issue and there was no device malfunction. No device was returned. The bhr was reviewed and no anomalies were found. Patient cultures came back negative and patient vision is improving.
Patient Sequence No: 1, Text Type: N, H10
[142461085]
The patient was evaluated post-op and suspected to have endophthalmitis. The patient was referred to a retinal specialist that day and began treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2019-00005 |
| MDR Report Key | 8529710 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2019-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CECIL CHRISINGER |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252846094 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2019-04-18 |
| Model Number | MAL-1001-1 |
| Catalog Number | MAL-1001-1 |
| Lot Number | 106192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-18 |