MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-18 for ULTRATINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc..
[1163315]
The physician implanted two devices 2007. One of the devices was not absorbing and was explanted by the physician. The reporter was not aware of the explant date. The physician's office has been contacted for more detailed info on the reported event, such as explant date, however the office was not able to provide any additional info.
Patient Sequence No: 1, Text Type: D, B5
[8435515]
The explanted device was not returned to the mfr for eval, therefore, a failure mode could not be determined. The batch record for this lot was reviewed, which contains no abnormal mfg events. The complaint rate for this lot is not considered 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 | 3003644133-2009-00017 |
| MDR Report Key | 1405864 |
| Report Source | 05 |
| Date Received | 2009-06-18 |
| Date of Report | 2009-05-18 |
| Date Mfgr Received | 2009-05-18 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2009-06-26 |
| 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 | 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 METTALIC BONE FIXATION FASTENER |
| Product Code | NDL |
| Date Received | 2009-06-18 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| Lot Number | 01806 |
| Device Expiration Date | 2008-06-30 |
| 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 | 2009-06-18 |