MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for SELF-THREADING MONOKA S1-1800U manufactured by Clinical Research Consultants, Inc..
[89732082]
Patient Sequence No: 1, Text Type: N, H10
[89732083]
It was reportedly noted prior to operative procedure that the sterilization indicator dots located on unopened monoka ritleng stent packaging indicated that the stents were not sterile. The date located on the package indicated that it was still sterile. Two packages with different lot numbers were noted to be expired by the color of the dot. These packages were removed from stock and given to the or materials management for follow up. No reported patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6961449 |
| MDR Report Key | 6961449 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-08 |
| Report Date | 2017-09-21 |
| Date Reported to FDA | 2017-09-21 |
| Date Reported to Mfgr | 2017-09-21 |
| Date Added to Maude | 2017-10-19 |
| 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 |
| 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 | 2017-10-19 |
| Model Number | S1-1800U |
| Lot Number | 1554385 |
| ID Number | 1554871 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL RESEARCH CONSULTANTS, INC. |
| Manufacturer Address | BARBARA FANT 3308 JEFFERSON AVE UPPER LEVEL CINCINNATTI OH 45220 US 45220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |