MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-28 for CRANIOPLASTIC 43-1280 manufactured by Codman & Shurtleff, Inc..
[101160056]
(b)(4) upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[101160057]
As reported by the ous affiliate, cranioplastic failed to solidify. No patient harm was reported, but there was a delay of 40 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2018-10193 |
| MDR Report Key | 7302900 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-28 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-02-28 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIOPLASTIC |
| Generic Name | METHYL METHACRYLATE FOR CRANIOPLASTY |
| Product Code | GXP |
| Date Received | 2018-02-28 |
| Catalog Number | 43-1280 |
| Lot Number | 8535448 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-28 |