MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-12-04 for CONNOR WAND 08-07114 8-07114 manufactured by Rhein Medical.
[116153]
A physician noted that the tip of an instrument was missing after use during eye surgery.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1051791-1998-00001 |
MDR Report Key | 200387 |
Report Source | 06 |
Date Received | 1998-12-04 |
Date of Report | 1998-11-05 |
Date of Event | 1998-10-15 |
Date Mfgr Received | 1998-11-05 |
Device Manufacturer Date | 1996-10-01 |
Date Added to Maude | 1998-12-08 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CONNOR WAND |
Generic Name | OPHTHALMIC SPATULA |
Product Code | HND |
Date Received | 1998-12-04 |
Model Number | 08-07114 |
Catalog Number | 8-07114 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 191424 |
Manufacturer | RHEIN MEDICAL |
Manufacturer Address | 5460 BEAUMONT CENTER BLVD. SUITE 500 TAMPA FL 33634 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1998-12-04 |