MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-28 for 20MM SPHERE * manufactured by Storz Opthalmus.
[220269]
In 2001, pt. Underwent an enucleation of the left eye secondary to neurotrophic keratiti's following radiation therapy for it maxillary sinus squamous cell carcinoma. Prior to this surgery pt was experiencing pain and pus like drainage. A 20mm ball implant was inserted. Subsequently, pt developed chills and purulent drainage (gram-positive cocci). Had prev. Been on clindamycin after the 1st surgery - which was then stopped. Eight days later, the implant was removed due to infection implant extruding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 364205 |
| MDR Report Key | 364205 |
| Date Received | 2001-11-28 |
| Date of Report | 2001-10-22 |
| Date of Event | 2001-10-19 |
| Date Reported to Mfgr | 2001-10-23 |
| Date Added to Maude | 2001-12-07 |
| 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 | 20MM SPHERE |
| Generic Name | SMALL CONFORMER |
| Product Code | HPZ |
| Date Received | 2001-11-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | S2297 |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 353305 |
| Manufacturer | STORZ OPTHALMUS |
| Manufacturer Address | 3365 TREE COURT INDUSTRIAL BLVD. ST. LOUIS MI * US |
| Baseline Brand Name | EYE SPHERE 20MM |
| Baseline Generic Name | EYE SPHERE IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | L1420 |
| Baseline ID | NA |
| Baseline Device Family | IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 61 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921106 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-11-28 |