MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-07-29 for BELIMED manufactured by Belimed Ag.
[19726192]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19833028]
Belimed technician evaluated the unit and found water leaking from the wash pump, either the shaft seals or casings, and from various hoses under the machine. Also noted were signs of corrosion and mold under the machine. The washer/disinfector is not maintained by belimed personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043641-2008-00001 |
| MDR Report Key | 3131174 |
| Report Source | 05,07 |
| Date Received | 2008-07-29 |
| Date Mfgr Received | 2008-07-17 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2013-05-29 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2284 CLEMENTS FERRY ROAD |
| Manufacturer City | CHARLESTON SC 28482 |
| Manufacturer Country | US |
| Manufacturer Postal | 28482 |
| Manufacturer Phone | 8432167424 |
| Manufacturer G1 | BELIMED AG |
| Manufacturer Street | DORFSTRASSE 4 |
| Manufacturer City | BALLWIL 6275 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6275 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BELIMED |
| Generic Name | WASHER/DISINFECTOR |
| Product Code | FLH |
| Date Received | 2008-07-29 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELIMED AG |
| Manufacturer Address | BALLWIL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-29 |