MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Johnson And Johnson/ Codman And Shurtleff.
[63133709]
Codman disposable perforator 14mm (lotjj011s) malfunctioned while in use by physician attending. Item removed from sterile field and was saved to be given to codman rep. Codman rep notified. A (b)(6), presented to ed with 2 days ha, and pain behind right eye, blurred vision, b/p elevated, head ct shown acute parenchymal hemorrhage, taken to operating room for craniotomy to evacuate hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066823 |
| MDR Report Key | 6193330 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-13 |
| Date Added to Maude | 2016-12-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | CRANIAL PERFORATOR |
| Product Code | KAT |
| Date Received | 2016-12-19 |
| Model Number | 26-1221 |
| Lot Number | JJO13S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF |
| Manufacturer Address | NEW BRUNSWICK NJ 08933 US 08933 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-19 |