MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for 2C V.1 manufactured by Morcher Gmbh/ Emergo Global Representation Llc.
[67946697]
Patient Sequence No: 1, Text Type: N, H10
[67946698]
During procedure, when loading 2 cionni rings with a capsular tension ring inserter, the distal eyelet was torn on both. The ring cannot be sutured into place with a torn eyelet, therefore the rings could not be used. A third ring was successfully used to complete the procedure as planned. No harm came to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6348694 |
| MDR Report Key | 6348694 |
| Date Received | 2017-02-22 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-02-03 |
| Report Date | 2017-02-20 |
| Date Reported to FDA | 2017-02-20 |
| Date Reported to Mfgr | 2017-02-20 |
| Date Added to Maude | 2017-02-22 |
| 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 | NA |
| Generic Name | RING, ENDOCAPSULAR |
| Product Code | MRJ |
| Date Received | 2017-02-22 |
| Model Number | 2C V.1 |
| Lot Number | BFAAKA |
| Device Expiration Date | 2019-12-31 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORCHER GMBH/ EMERGO GLOBAL REPRESENTATION LLC |
| Manufacturer Address | 2500 BEE CAVE ROAD BLDG 1, STE 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-22 |