MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for MCPHERSONS ROTATOR P505 manufactured by Bausch + Lomb.
[121722203]
The hospital reported that the instrument involved in this event was from "(b)(4)". However, the review of our records, systems and catalogs did not find any information regarding the manufacturing of this instrument. We are reporting this event base on the information provided in the report by the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[121722204]
We were notified by the (b)(6) of an incident reported to them by (b)(6) hospital in (b)(6). The report stated that while the instrument was being used, a small part of the tip broke off in the patient's eye. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2018-00127 |
| MDR Report Key | 7899314 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-05-02 |
| Date Added to Maude | 2018-09-21 |
| 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 | JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCPHERSONS ROTATOR |
| Generic Name | OPHTHALMIC INSTRUMENT |
| Product Code | HMF |
| Date Received | 2018-09-21 |
| Model Number | P505 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-09-21 |