MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for STAMMBERGER SINUS DRESSING RR 650 manufactured by Arthrocare Corporation.
[69498527]
Patient Sequence No: 1, Text Type: N, H10
[69498528]
It was reported that during a case it was noticed that the stammberger sinus dressing did not have a syringe in the packaging, the case was completed by using another vendors product. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[74192397]
The product, intended for use in treatment, was returned for evaluation. There was a relationship between the product and the reported event. Visual observation of the returned sealed inner tray confirmed the molded cannula was missing. A functional evaluation was not required as the complaint was not related to the functionality of the product. The complaint regarding the missing? Syringe? Has been verified. The root cause of this event is due to a workmanship related issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2017-00055 |
| MDR Report Key | 6381106 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE CORPORATION |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAMMBERGER SINUS DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-03-06 |
| Returned To Mfg | 2017-03-06 |
| Catalog Number | RR 650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |