MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for CRANIOPLASTIC 43-1280 manufactured by Codman & Shurtleff, Inc..
[80661139]
(b)(4). It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time, this complaint is considered closed. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[80661140]
It was reported that the surgeon felt that the curing speed of the resin was faster than usual during the surgery on (b)(6) 2017. The surgeon was familiar with how to use the product, and the product was kept in the refrigerator. Since the product was used for the patient, it was not possible to return the product. There was no adverse consequence to the patient. No further information was provided by hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-10498 |
| MDR Report Key | 6725396 |
| Date Received | 2017-07-19 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-07-19 |
| 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 | 0 |
| Brand Name | CRANIOPLASTIC |
| Generic Name | METHYL METHACRYLATE FOR CRANIOPLASTY |
| Product Code | GXP |
| Date Received | 2017-07-19 |
| Catalog Number | 43-1280 |
| Lot Number | 8159206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-07-19 |