MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-03-19 for STORZ CASTROVIEJO SPATULA E0474 manufactured by Bausch & Lomb, Inc..
[16059254]
The user facility in (b)(6), reported a scleral tear as the instrument was in contact with the pt's eye. Suture was required to close the wound.
Patient Sequence No: 1, Text Type: D, B5
[16382577]
Report 1 of 4. See 1920664-2014-0039, 1920664-2014-0040, 1920664-2014-0041.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2014-00027 |
| MDR Report Key | 3709220 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-02-18 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-02-18 |
| Date Added to Maude | 2014-03-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON SPENCER, DIRECTOR |
| Manufacturer Street | 50 TECHNOLOGY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ CASTROVIEJO SPATULA |
| Product Code | HND |
| Date Received | 2014-03-19 |
| Catalog Number | E0474 |
| Lot Number | NA |
| 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 | 2014-03-19 |