MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-08-11 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[391234]
Customer reports that while drilling a bone flap on a craniotomy, the perforator did not stop. Customer does not think the patient's dura was damaged. Customer has not determined if device will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2004-00252 |
| MDR Report Key | 618537 |
| Report Source | 05,06 |
| Date Received | 2004-08-11 |
| Date of Report | 2004-07-13 |
| Date of Event | 2004-07-13 |
| Date Mfgr Received | 2004-07-13 |
| Date Added to Maude | 2005-07-01 |
| 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 |
| 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 | 2004-08-11 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | UNK |
| 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 | 608222 |
| 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 | 2004-08-11 |