MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-07-22 for STERILE DISPOSABLE TREPHINE BLADE 9.0MM 0009717 manufactured by Medtronic Xomed, Inc..
[268783]
Customer reported that box contained the wrong size trephine blades-10mm blades instead of the 9mm that was printed on the product label. The customer returned the product in it's original unopened sterile pouches. The returned product inside of the boxes labeled 0009717 were actually part number 0009721, lot number 25214300.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2002-00012 |
| MDR Report Key | 405862 |
| Report Source | 06 |
| Date Received | 2002-07-22 |
| Date of Report | 2002-07-19 |
| Date of Event | 2002-06-10 |
| Date Mfgr Received | 2002-06-10 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2002-07-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BILL WIGGINS |
| Manufacturer Street | 6743 SOUTHPOINT DR. N. |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328196 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE DISPOSABLE TREPHINE BLADE 9.0MM |
| Generic Name | DISPOSABLE OPHTHALMIC INSTRUMENT |
| Product Code | HRH |
| Date Received | 2002-07-22 |
| Returned To Mfg | 2002-06-19 |
| Model Number | 0009717 |
| Catalog Number | 0009717 |
| Lot Number | 25209500 |
| ID Number | * |
| Device Expiration Date | 2010-05-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 394851 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | STERILE DISPOSABLE TREPHINE BLADE 9.0MM |
| Baseline Generic Name | DISPOSABLE OPHTHALMIC INSTRUMENT |
| Baseline Model No | 0009717 |
| Baseline Catalog No | 0009717 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-22 |