MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-27 for CODMAN manufactured by Codman.
[572205]
Admitted from another acute care facility in 2005 after fall. Diagnosed with a large right acute subdural hematoma with minor chronic component. Prior to surgical intervention at this facility, the pt's coagulopathy was reversed with ffp, platelets, and intravenous ddavp. In 2005 an operative evacuation of the subdural hematoma by standard craniotomy was performed. The first two burr holes were created without difficulty while creating the third burr hole posteriorly, the dual perforated bit, but not stop. The drill was prevented from plunging deep by the surgeon's hands, but none the less a laceration of the dura and a small cortical laceration occurred. The region was inspected, irrigated, electro-cauterized, and a little bit of gel foam was placed. There did not appear to be any major intraparenchymal hemorrhage at that level, nor any brain swelling. As the surgery progressed brain swelling occurred. The level of the third burr hole was re-explored, but no obvious intraparenchymal hematoma was seen, but rather swollen white matter. Due to this malignant brain swelling, an immediate frontal and temporal lobectomy was done. After completion of surgery the, pt was taken to the ct scanner and then to the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 786114 |
| MDR Report Key | 786114 |
| Date Received | 2005-06-27 |
| Date of Report | 2005-06-01 |
| Date of Event | 2005-05-20 |
| Date Facility Aware | 2005-05-23 |
| Report Date | 2005-06-01 |
| Date Reported to Mfgr | 2005-06-01 |
| Date Added to Maude | 2006-11-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | DISPOSABLE PERFORATOR |
| Product Code | KAT |
| Date Received | 2005-06-27 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | DX821 |
| ID Number | 26-1221 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 773913 |
| Manufacturer | CODMAN |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 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. Life Threatening; 2. Required No Informationntervention | 2005-06-27 |