MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-02-01 for STORZ SPAINDE SCLERAL DEPRESSOR E5112 E0103 manufactured by Bausch & Lomb, Inc..
[2557343]
A report from the user facility reported the ophthalmologist was performing an eye exam using a scleral depressor on a 9 week old preemie. A sub-conjunctival bleed was noted. The tip of the instrument was noted to have a sharp burr. On closer inspection a hairline crack was noted on the tip of the instrument.
Patient Sequence No: 1, Text Type: D, B5
[9590241]
The user facility will not be returning the instrument for evaluation. Additional information has been requested from the user facility concerning the patient's outcome. No response has been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2012-00014 |
| MDR Report Key | 2438154 |
| Report Source | 06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-03 |
| Date of Event | 2011-11-08 |
| Date Mfgr Received | 2012-01-03 |
| Date Added to Maude | 2012-04-06 |
| 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 TRELFORD, 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 SPAINDE SCLERAL DEPRESSOR |
| Generic Name | SCLERAL DEPRESSOR |
| Product Code | HNX |
| Date Received | 2012-02-01 |
| Model Number | E5112 |
| Catalog Number | E0103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-02-01 |