MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-06-27 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[548501]
Customer reports disposable perforator failed to disengage while patient was undergoing evacuation of a subdural hematoma. There was a minor tear of the dura. Pt has other non-perforator related difficulties and is currently in icu.
Patient Sequence No: 1, Text Type: D, B5
[7803914]
Codman has requested return of the perforator for eval. Historically for complaints of this nature, the returned perforators have been visually inspected as received, disassembled and cleaned, and then visually and dimensionally inspected. No discrepancies have been found. The perforators have been reassembled and were functionally tested for cutting and drilling. They've been found to meet specification requirements. The reported condition could not be duplicated reviews of the device history records have found no discrepancies. The complaints have not been confirmed. A follow up report will be filed if the investigation of this device reveals a result different from that which is stated above or if any further info regarding the cause or model of failure is made available. Otherwise, the complaint is considered to be closed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2005-00145 |
| MDR Report Key | 786156 |
| Report Source | 06 |
| Date Received | 2005-06-27 |
| Date of Event | 2005-05-20 |
| Date Mfgr Received | 2005-05-31 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-11-27 |
| 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 | NEW BEDFORD INDUSTRIAL PARK |
| Manufacturer City | NEW BEDFORD MA 02745 |
| Manufacturer Country | US |
| Manufacturer Postal | 02745 |
| Manufacturer Phone | 5088283106 |
| 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 | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES |
| Product Code | KAT |
| Date Received | 2005-06-27 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | DX821 |
| ID Number | NA |
| Device Expiration Date | 2010-04-30 |
| 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 | 773913 |
| 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 | 2005-06-27 |