MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-04-01 for VENTURI PHACO PACK DP4310E manufactured by Bausch & Lomb.
[812056]
The spike came out of the tubing when the machine advanced to segment removal. This resulted into the anterior chamber collapsing and the capsule tearing. An anterior vitrectomy had to be performed. The pt recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2008-00407 |
| MDR Report Key | 1024428 |
| Report Source | 06,07 |
| Date Received | 2008-04-01 |
| Date of Report | 2008-02-18 |
| Date of Event | 2008-02-18 |
| Date Mfgr Received | 2008-02-18 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2008-04-09 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 631226694 |
| Manufacturer Country | US |
| Manufacturer Postal | 631226694 |
| Manufacturer Phone | 6362263213 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTURI PHACO PACK |
| Generic Name | OPHTHALMIC MICROSURGICAL ACCESSORY PACK |
| Product Code | MSR |
| Date Received | 2008-04-01 |
| Catalog Number | DP4310E |
| Lot Number | T9196 |
| Device Expiration Date | 2009-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992316 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-01 |