MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for TAMPONADE ANTERIOR/POSTERIOR RR 900 manufactured by Arthrocare Corp..
[28447206]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28447207]
It was reported that two 9cm nasal dressings were improperly placed with the protective plastic sheath still in situ resulting in nasal mucosal damage and epistaxis. The patient was successfully treated (for nose bleed) and released on the same day. Subsequent recovery was uneventful.
Patient Sequence No: 1, Text Type: D, B5
[36865083]
Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation. Thus, the customer? S complaint could not be verified, nor could a root cause be determined with confidence. There are no indications to suggest the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2015-00535 |
| MDR Report Key | 5154584 |
| Date Received | 2015-10-15 |
| Date of Report | 2016-01-25 |
| Date Mfgr Received | 2015-09-24 |
| Date Added to Maude | 2015-10-15 |
| 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 | MR. JIM GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DR. |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913900 |
| Manufacturer G1 | ARTHROCARE CORP. |
| 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 | TAMPONADE ANTERIOR/POSTERIOR |
| Generic Name | SPLINT, NASAL |
| Product Code | EPP |
| Date Received | 2015-10-15 |
| Catalog Number | RR 900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-15 |