MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-18 for CODMAN DISPOS PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[19495730]
Customer reports that a disposable perforator malfunctioned during procedure, causing a perforation of the dura.
Patient Sequence No: 1, Text Type: D, B5
[19812158]
It has been confirmed that the device is not available for eval. Without the device, codman is unable to conduct a proper investigation. Codman did however receive a lot number; therefore a review of the device history records will be performed. We anticipated that the records review will reveal the product conformed to all testing and manufacturing specifications. If anything otherwise is noted, a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2006-00203 |
| MDR Report Key | 742810 |
| Report Source | 06 |
| Date Received | 2006-07-18 |
| Date of Event | 2006-04-24 |
| Date Mfgr Received | 2006-06-23 |
| Date Added to Maude | 2006-08-03 |
| 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 DISPOS PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES & ACC. |
| Product Code | KAT |
| Date Received | 2006-07-18 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | MX824 |
| 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 | 710358 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRAIL PARK NEW BEDFORD MA 02745 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-18 |