MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-08 for ALFONZO EYE SPECULUM NEWBORN UNK 5-5223 manufactured by Msi Precision Specialty Instruments.
[20159706]
Ophthalmologist used speculum during routine eye exam on newborn. After completing the exam; upon removal of the speculum from the eye, physician observed that a portion of the speculum had broken off leaving a sharp edge. An x-ray was obtained to rule out a piece of speculum lodging in the eye. X-ray negative. Eye exam conducted to rule out any injury from broken speculum. Eye exam normal. Manufacturer response (as per reporter) for speculum, opthalmic, ophthalmic speculum (item #615w411200-00). They sold over 800 speculums without report of breakage. Conceded that breakage would depend on the care and handling of the speculum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1586374 |
| MDR Report Key | 1586374 |
| Date Received | 2010-01-08 |
| Date of Report | 2010-01-08 |
| Date of Event | 2009-11-11 |
| Report Date | 2010-01-08 |
| Date Reported to FDA | 2010-01-08 |
| Date Added to Maude | 2010-01-26 |
| 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 |
| 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 | ALFONZO EYE SPECULUM NEWBORN |
| Generic Name | SPECULUM, OPTHALMIC |
| Product Code | HNC |
| Date Received | 2010-01-08 |
| Model Number | UNK |
| Catalog Number | 5-5223 |
| Lot Number | UNK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MSI PRECISION SPECIALTY INSTRUMENTS |
| Manufacturer Address | 1220 VALLEY FORGE ROAD, BLD 34 PHOENIXVILLE PA 19460 US 19460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-08 |