MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-12 for 25G BI-B COMBINED ELITE W WF SE5525WVB manufactured by Bausch + Lomb.
[183174841]
The sterilization and lot history records were reviewed and found to be acceptable. Investigation ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183174842]
A bi-blade cutter stopped with the cut door open. Aspiration continued with a problem from the external hole. The cutter was replaced from a new pack. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00051 |
| MDR Report Key | 9824305 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-22 |
| Date of Event | 2020-02-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-12 |
| 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 63121 |
| Manufacturer Country | US |
| Manufacturer Postal | 63121 |
| Manufacturer Phone | 6362263220 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25G BI-B COMBINED ELITE W WF |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-12 |
| Model Number | SE5525WVB |
| Catalog Number | SE5525WVB |
| Lot Number | W3539 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |