MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-08 for ULTRATINE FOREHEAD 3.0 23201 20201 manufactured by Coapt Systems, Inc..
[22102698]
It has been reported that the physician implanted the device in 2008. Months following the surgery, the pt developed a cystic inflammatory mass in the area of implantation. The physician explanted the mass under local anesthesia in 2009.
Patient Sequence No: 1, Text Type: D, B5
[22118834]
The explanted material was not returned to the mfr, therefore, a physical eval to determine failure mode could not be performed. The batch record for this lot has been reviewed, which contains no abnormal mfg events. The complaint rate for this lot is not abnormal for this device. If additional info becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00029 |
| MDR Report Key | 1469041 |
| Report Source | 05 |
| Date Received | 2009-09-08 |
| Date of Report | 2009-08-17 |
| Date of Event | 2009-08-03 |
| Date Mfgr Received | 2009-08-17 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-09-21 |
| 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 | LINDA RUEDY, DIR |
| Manufacturer Street | 1820 EMBARCADERO RD. |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6504617600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATINE FOREHEAD 3.0 |
| Generic Name | SMOOTH METALLIC BONE FIXATION FASTENER |
| Product Code | NDL |
| Date Received | 2009-09-08 |
| Model Number | 23201 |
| Catalog Number | 20201 |
| Lot Number | 02092 |
| Device Expiration Date | 2010-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COAPT SYSTEMS, INC. |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-08 |