MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-11-20 for CODMAN DISPOS PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[751296]
Affiliate reported a disengagement failure. During the operation, perforator couldn't stop and it caused dura injury and brain contusion to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8034604]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2007-00311 |
| MDR Report Key | 950095 |
| Report Source | 01,07 |
| Date Received | 2007-11-20 |
| Date of Event | 2007-10-26 |
| Date Mfgr Received | 2007-10-28 |
| Date Added to Maude | 2007-11-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATHEW 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 |
| 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 | 2007-11-20 |
| Returned To Mfg | 2007-11-06 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | GZ804 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 922921 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-20 |