MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-07-12 for L-CLIP TRAY TAG FOR 45.728 TAG-45.728 manufactured by Depuy Synthes Power Tools.
[22196288]
It was reported that during pre-testing it was observed that the "color was flaking off" of the labels on the aneurysm tray device. According to the report, the user observed that there was "bubbling" under the paint. The reporter indicated that the "pink color" seemed to be affected the most. The actual device was used in the scheduled surgery and surgery was completed successfully. There were no reports of injuries, adverse events, or medical intervention. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[22324200]
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2013-02741 |
| MDR Report Key | 3224207 |
| Report Source | 05,06,07 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-06-18 |
| Date of Event | 2013-06-14 |
| Date Mfgr Received | 2013-06-18 |
| Date Added to Maude | 2013-10-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5614943766 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-CLIP TRAY TAG FOR 45.728 |
| Generic Name | APPLIER, ANEURYSM CLIP |
| Product Code | HCI |
| Date Received | 2013-07-12 |
| Catalog Number | TAG-45.728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-12 |