MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-28 for CODMAN MODULAR AIR DRIVER 26-5000 manufactured by J&j Prof, Inc.
[10564119]
Upon completion of the investigation it was noted that the vendor's evaluation revealed that instruments were corroded, missing components, and worn. The condition of these instruments is associated with excessive use over a long period of time. Instruments are old and are out of warranty. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
[16534435]
The affiliate reported that the secure do not allow the activation of the equipment and the trephone piece got stuck. Affiliate reported dalay in surgery as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[16623489]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2012-84134 |
| MDR Report Key | 2889124 |
| Report Source | 01,07 |
| Date Received | 2012-12-28 |
| Date of Event | 2012-11-07 |
| Date Mfgr Received | 2012-11-29 |
| Date Added to Maude | 2013-03-26 |
| 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 | MR MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN MODULAR AIR DRIVER |
| Generic Name | CRANIOTOME DRIVER |
| Product Code | KFK |
| Date Received | 2012-12-28 |
| Returned To Mfg | 2013-01-08 |
| Catalog Number | 26-5000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J&J PROF, INC |
| Manufacturer Address | 7410 SAN FERNANDO RD SUN VALLEY CA 91352 US 91352 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-28 |