MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-08 for SPAIDE PEDIATRIC SCLERAL DEPRESSOR E5112 * manufactured by Bausch & Lomb, Storz Ophthalmics.
[2499658]
The ophthalomologist was performing an eye exam using a scleral depressor on a 9 week old premie. A subconjunctival bleed was noted. The tip of the instrument was noted to have a sharp burr. On closer inspection a hairline crack was noted at the tip of the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2383076 |
| MDR Report Key | 2383076 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-11-28 |
| Date of Event | 2011-11-08 |
| Report Date | 2011-11-28 |
| Date Reported to FDA | 2011-12-08 |
| Date Added to Maude | 2011-12-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPAIDE PEDIATRIC SCLERAL DEPRESSOR |
| Generic Name | SCLERAL DEPRESSOR |
| Product Code | HNX |
| Date Received | 2011-12-08 |
| Model Number | E5112 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, STORZ OPHTHALMICS |
| Manufacturer Address | 499 SOVEREIGN CT. MANCHESTER MO 63011 US 63011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-08 |