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 |