MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-01 for ULTRATINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc..
[20509745]
It has been reported that the physician implanted two devices in 2009. The pt developed a "bump" on the left side of the forehead in the area of implantation. The physician removed the mass under local anesthesia eight months later. The physician identified the mass as encapsulation of the device. The capsule was soft and easy to remove. No remains of the device were seen. The pt did show some reaction to vicryl sutures.
Patient Sequence No: 1, Text Type: D, B5
[20814302]
The explanted material was not returned to the mfr, therefore an investigation to determine failure mode could not be conducted. The batch record for this lot has been reviewed, which contains no abnormal manufacturing events. The complaint rate for this lot is not abnormal of this device. The physician was contacted by the mfr regarding this issue. If add'l info becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00030 |
| MDR Report Key | 1491331 |
| Report Source | 05 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-21 |
| Date of Event | 2009-09-21 |
| Date Mfgr Received | 2009-09-21 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2009-10-13 |
| 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, DIRECTOR |
| 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 | 2009-10-01 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| Lot Number | 02251 |
| Device Expiration Date | 2010-08-31 |
| 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 | 2009-10-01 |