MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-04-19 for HARDY CURETTE 80-1346 manufactured by Codman & Shurtleff, Inc..
[369829]
Per user facility report# 0300640000-2005-8005: a pt had an abnormality of the sphenoid sinus noted on a ct and an mri. The pt had a history of leimyosarcoma of the retroperitoneum. The mass was biopsied using a transeptal approach. During the procedure, a 3mm transphenoidal curette was used. The tip broke off the curette and the operating surgeon was unable to locate it. A c-arm was brought in but followed the x-ray, the tip was found on the drape. The x-ray showed nothing was inside the pt. The pt was determined to be uninjured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2005-00099 |
| MDR Report Key | 593572 |
| Report Source | 05,06 |
| Date Received | 2005-04-19 |
| Date of Event | 2005-03-07 |
| Date Mfgr Received | 2005-03-28 |
| Date Added to Maude | 2005-04-22 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | NEW BEDFORD INDUSTRIAL PARK |
| Manufacturer City | NEW BEDFORD MA 02745 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARDY CURETTE |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2005-04-19 |
| Model Number | NA |
| Catalog Number | 80-1346 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 573470 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US |
| Baseline Brand Name | HARDY CURETTE |
| Baseline Generic Name | CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 80-1346 |
| Baseline ID | NA |
| Baseline Device Family | HARDY CURETTE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-19 |