MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-11 for STORZ DECEMET KELLY MEMBRANE PUNCH E2798 manufactured by Bausch & Lomb, Inc..
[2593822]
A report from the user facility reported "an (b)(6) female underwent a trabeculectomy with mitomycin-c to her right eye and phacoemulsification with intraocular lens implantation with the use of malyugin in the right eye on (b)(6) 2012. Intraoperatively, the kelly punch broke at 2. 5 mm of the tip fragment was retrieved from the pt's right eye flap". The pt was discharged from the hospital; however, the pt's outcome, though requested, has not been supplied by the user facility to bausch & lomb.
Patient Sequence No: 1, Text Type: D, B5
[9956842]
The user facility reported via voluntary report (b)(4). The user facility reported the device will not be returned for evaluation. A supplemental report will be filed, should additional information be received or the device become available for investigation. Correction to voluntary user facility report: (b)(4). The kelly punch was identified as serial number (b)(4); however, the number does not correspond to bausch & lomb kelly punch instruments. The correct number has been provided in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2012-00060 |
| MDR Report Key | 2542964 |
| Report Source | 06 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-05-17 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON SPENCER, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE STE: 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ DECEMET KELLY MEMBRANE PUNCH |
| Generic Name | DECEMET KELLY MEMBRANE PUNCH |
| Product Code | HNJ |
| Date Received | 2012-04-11 |
| Model Number | E2798 |
| Catalog Number | E2798 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-11 |