MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-21 for RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM SIS100B manufactured by Acclarent.
[4758559]
The user reported having received the subject device in an open pouch. All other devices within the same box were examined and confirmed to be sealed. A device from a sealed pouch was used to perform the procedure. The phenomenon was discovered before use, and there was no adverse impact to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[12315102]
The device, with its original packaging, was received and evaluated. Acclarent confirmed that no seal was present at the bottom edge of the returned pouch. Acclarent has taken steps to reduce the likelihood of recurrence, and will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00021 |
| MDR Report Key | 4093141 |
| Report Source | 05 |
| Date Received | 2014-08-21 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-08-01 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2014-09-19 |
| 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 | IZABEL NIELSON, SR MGR |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM |
| Product Code | KAM |
| Date Received | 2014-08-21 |
| Returned To Mfg | 2012-08-09 |
| Model Number | NA |
| Catalog Number | SIS100B |
| Lot Number | 120306D-CM |
| ID Number | NA |
| Device Expiration Date | 2014-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |