MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2010-12-07 for RUSCH EPISTAXIS AIRWAY, 6ML 209302020 manufactured by Willy Ruesch Gmbh.
[1684011]
The event is reported as: the vessel isn't air tight. Additional info suggests that the inflation system or the balloon is not tight/leaking. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8810676]
The device sample was sent directly to the mfg site in (b)(4). The returned date is unk. Method: other - review of mfg process. Results: other - the visual examination of the returned device revealed strong traces of usage and damages. The tip is torn at about 1. 5cm directly at the balloon winding. The inflation line is torn out. The balloon windings are contaminated. The tube shaft is damaged in the area of the product markings. A review of the mfg process and the used raw material did not show any irregularities. The review of the complaint data base as of january 2008 to present showed one other complaint for this issue. Conclusions: other - the condition of the returned device showed that strong pulling forces have been applied on the tube tip and the inflation line, so that they were heavily torn. Most probably the observed damages were procedure related. The mfg site will monitor this product with regard to this reported complaint description.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610520-2010-00016 |
| MDR Report Key | 1933873 |
| Report Source | 01,06,07 |
| Date Received | 2010-12-07 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-10-01 |
| Date Mfgr Received | 2010-11-15 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2011-04-04 |
| 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 | MICHAEL TAGGART, VP |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334816 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUSCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EPISTAXIS AIRWAY, 6ML |
| Generic Name | EPISTAXIS AIRWAY |
| Product Code | EMX |
| Date Received | 2010-12-07 |
| Model Number | NA |
| Catalog Number | 209302020 |
| Lot Number | 09431 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUESCH GMBH |
| Manufacturer Address | KERNEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-07 |