MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for RITLENG HOOK S1-1480U manufactured by Fci Ophthalmics Inc.
[26651407]
Patient Sequence No: 1, Text Type: N, H10
[26651408]
The ritleng hook was used during a procedure to pull a stent through nares. When the hook was removed it was noted that the tip of the hook was missing. An x-ray was obtained and a small object was noted in the image. The missing tip was found and removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5100054 |
| MDR Report Key | 5100054 |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-08-31 |
| Report Date | 2015-09-22 |
| Date Reported to FDA | 2015-09-22 |
| Date Reported to Mfgr | 2015-09-22 |
| Date Added to Maude | 2015-09-24 |
| 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 | 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 | RITLENG HOOK |
| Generic Name | HOOK, OPHTHALMIC |
| Product Code | HNQ |
| Date Received | 2015-09-24 |
| Catalog Number | S1-1480U |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FCI OPHTHALMICS INC |
| Manufacturer Address | 20 WINTER ST EAST PEMBROKE MA 02359 US 02359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |