MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-08-17 for ESCALON TR9060-61 manufactured by Escalon Medical.
[16621254]
The reported cases involved vitrectomy, followed by fluid/air exchange and then c3f8 administration. Standard 24-hour post-surgical evaluation detected elevated intraocular pressure, which subsequently had to be relieved. Problems were found in four out of approx 30 cases performed over the past several months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183477-1998-00002 |
| MDR Report Key | 183204 |
| Report Source | 05,06 |
| Date Received | 1998-08-17 |
| Date of Report | 1998-08-14 |
| Date Mfgr Received | 1998-07-15 |
| Date Added to Maude | 1998-08-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESCALON |
| Generic Name | UNIVERSAL GAS KIT |
| Product Code | BXX |
| Date Received | 1998-08-17 |
| Model Number | NA |
| Catalog Number | TR9060-61 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 178121 |
| Manufacturer | ESCALON MEDICAL |
| Manufacturer Address | 2440 SOUTH 179TH STREET NEW BERLIN WI 53146 US |
| Baseline Brand Name | ESCALON |
| Baseline Generic Name | UNIVERSAL GAS KIT |
| Baseline Model No | NA |
| Baseline Catalog No | TR9060-61 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923397 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-08-17 |