MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-29 for STELLARIS PC MIDFIELD ENDOILLUMINATOR BL5827M manufactured by Bausch + Lomb.
[112743647]
The sterilization and lot history records were reviewed and found to be acceptable. Report 2 of 7 see: 1932402-2018-00004, 00006, 00007, 00008, 00009, 00010.
Patient Sequence No: 1, Text Type: N, H10
[112743648]
It was reported the patient developed endophthalmitis after a procedure in which bausch + lomb devices were used. The cause of the endophthalmitis has not been determined. Additional information regarding possible treatment and patient outcome has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2018-00005 |
| MDR Report Key | 7650715 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-06-08 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2018-06-29 |
| 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 | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLARIS PC MIDFIELD ENDOILLUMINATOR |
| Generic Name | 27GA MIDFIELD ENDOILLUMINATOR |
| Product Code | MPA |
| Date Received | 2018-06-29 |
| Model Number | BL5827M |
| Lot Number | M0015484 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |