MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-16 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[37438406]
The perforator has been returned for evaluation. A follow-up report will be filed upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[37438407]
It was reported that the disposable perforator plunged when drilling during a craniotomy and had to be retrieved. No harm to patient. Dura was not torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2004-00286 |
| MDR Report Key | 5311037 |
| Date Received | 2004-09-16 |
| Date of Event | 2004-08-27 |
| Date Mfgr Received | 2004-08-27 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2015-12-18 |
| 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 | 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 | 0 |
| Brand Name | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES AND ACCESSORIES |
| Product Code | HBG |
| Date Received | 2004-09-16 |
| Returned To Mfg | 2004-09-30 |
| Model Number | NA |
| Catalog Number | 26-1221 |
| Lot Number | LV878 |
| ID Number | NA |
| Device Expiration Date | 2008-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2004-09-16 |