MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2009-08-11 for 5MM X 32CM PROBE AND VALVE C6001 100637601 manufactured by Applied Medical Resources.
[20623607]
"the suction was blocked while operating in surgery. There are two suctions show the same problem. But customer has already abandoned another one. "
Patient Sequence No: 1, Text Type: D, B5
[20827142]
Upon receipt and evaluation of the incident device, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2009-00078 |
| MDR Report Key | 1448945 |
| Report Source | 06,08 |
| Date Received | 2009-08-11 |
| Date of Report | 2009-08-11 |
| Date of Event | 2009-07-30 |
| Date Facility Aware | 2009-07-30 |
| Report Date | 2009-08-11 |
| Date Reported to Mfgr | 2009-07-30 |
| Date Mfgr Received | 2009-07-30 |
| Date Added to Maude | 2009-10-29 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JAN RANK |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138237 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5MM X 32CM PROBE AND VALVE |
| Generic Name | SUCTION IRRIGATOR |
| Product Code | FHF |
| Date Received | 2009-08-11 |
| Model Number | C6001 |
| Catalog Number | 100637601 |
| Lot Number | 1080000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-08-11 |