MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-07 for ULTRATINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc..
[1204539]
In 2008, the physician implanted two devices. The patient developed protruding bumps in the area of implantation postoperatively. In 2009, the physician removed the devices.
Patient Sequence No: 1, Text Type: D, B5
[8395962]
The physician provided photos of the explanted material, however, the material was not returned to the manufacturer for evaluation. Therefore, a failure mode could not be determined. The batch record for this lot has been reviewed and contains no abnormal manufacturing events. There is a very low occurence rate of patient reaction to this device. If additional information becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00013 |
| MDR Report Key | 1378292 |
| Report Source | 05 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-04-08 |
| Date of Event | 2009-04-08 |
| Date Mfgr Received | 2009-04-08 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-05-13 |
| 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 ROAD |
| 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 | 2009-05-07 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| 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 | 2009-05-07 |