MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-03-20 for DIAMOND RASP, CURVED N4503 manufactured by Bausch & Lomb.
[273197]
A piece of the nasal file detached during a rhinoplasty procedure and became lodged in the patient's nasal passage, which caused an abscess. A second procedure was requried to remove piece. There were no further problems reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-2002-00003 |
| MDR Report Key | 383125 |
| Report Source | 05 |
| Date Received | 2002-03-20 |
| Date of Report | 2002-02-20 |
| Date Mfgr Received | 2002-02-20 |
| Date Added to Maude | 2002-03-22 |
| 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 | JULI MOORE |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63112 |
| Manufacturer Country | US |
| Manufacturer Postal | 63112 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMOND RASP, CURVED |
| Generic Name | DIAMOND SURFACE RASP |
| Product Code | GAC |
| Date Received | 2002-03-20 |
| Returned To Mfg | 2002-02-28 |
| Model Number | NA |
| Catalog Number | N4503 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 372192 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 499 SOVEREIGN COURT MANCHESTER MO 63011 US |
| Baseline Brand Name | DIAMOND RASP, CURVED |
| Baseline Generic Name | DIAMOND SURFACE RASP |
| Baseline Model No | NA |
| Baseline Catalog No | N4503 |
| Baseline ID | NA |
| Baseline Device Family | MANUAL SURGICAL INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-03-20 |