MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-05 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[37528582]
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 information regarding the cause or mode of failure is made available. Otherwise, the complaint is considered to be closed at this time.
Patient Sequence No: 1, Text Type: N, H10
[37528583]
Affilate reports the disposable perforator failed to disengage while drilling during a craniotomy. No injury resulted. The perforator is not available for evaluation. The specific lot code for this device is unknown. However, the affiliate believes it may have been one of the following lot codes: gw849, g2866, gw869, gw894, gw897, hw836, jw899, cw884, cw924, dw815, d2829.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2005-00003 |
| MDR Report Key | 5369597 |
| Date Received | 2005-01-05 |
| Date Mfgr Received | 2004-12-07 |
| Date Added to Maude | 2016-01-15 |
| 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 | 3 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283105 |
| 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 | 0 |
| Brand Name | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES AND ACCESSORIES |
| Product Code | HBG |
| Date Received | 2005-01-05 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US 02745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-05 |