MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-06-22 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[471273]
Safety officer reported that perforator did not stop revolving when drilling into pt's skull. Reported that after use, the perforator was sterilized and its blue plastic sleeve melted. User facility report received 6/16/05 reports: a bilateral burr hole for a subdural hematoma evacuation was being done by using an anspatch drill with a codman perforator. The perforator went through the skull and dura. After the perforator penetrated the skull, the cutting mechanism did not disengage. The surgeon had to make the area of the bone flap larger in order to remove the bit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2005-00140 |
| MDR Report Key | 709451 |
| Report Source | 06 |
| Date Received | 2005-06-22 |
| Date of Event | 2005-04-16 |
| Date Mfgr Received | 2005-05-26 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2006-05-10 |
| 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 | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES |
| Product Code | KAT |
| Date Received | 2005-06-22 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | LW824 |
| ID Number | NA |
| Device Expiration Date | 2009-11-30 |
| 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 | 589867 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US |
| Baseline Brand Name | CODMAN DISPOSABLE PERFORATOR |
| Baseline Generic Name | COMPOUND DRILL |
| Baseline Model No | NA |
| Baseline Catalog No | 26-1221 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-22 |