MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for SELF-THREADING MONOKA S1.1800U manufactured by Clinical Research Consultants, Inc..
[117467174]
Provider placed the stent in the left eye. The stent was not in the correct position and was removed. A replacement stent was requested. When comparing the two stents (#s1. 1800u reference number), there was a significant difference in length of the peek (polyetheretherketone) thread guide. The difference in length from the ex-planted stent and the newly opened stent was 155 mm. Unused stent with the same lot number (#1754308028) was the incorrect length. Manufacturer response for stent monoka self threading, self-threading monoka (ritleng type) (per site reporter): no response yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7792979 |
| MDR Report Key | 7792979 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-06-11 |
| Report Date | 2018-07-19 |
| Date Reported to FDA | 2018-07-19 |
| Date Reported to Mfgr | 2018-08-17 |
| Date Added to Maude | 2018-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELF-THREADING MONOKA |
| Generic Name | PLUG, PUNCTUM |
| Product Code | LZU |
| Date Received | 2018-08-17 |
| Catalog Number | S1.1800U |
| Lot Number | 1754308028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL RESEARCH CONSULTANTS, INC. |
| Manufacturer Address | 3308 JEFFERSON AVE CINCINNATI OH 45220 US 45220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |