MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-29 for FUSA F4 (HF/PS/0.65/L) 0500161A manufactured by Ogden Manufacturing.
[1848896]
An initial report has been rec'd from a hemodialysis user facility of a dialyzer that leaked at the header cap during treatment. The facility was contacted and the following limited info was obtained. The involved pt is a toddler weighing less than 20 kg and that the pt is treated on an out pt basis. The pt suffered no ill effect as the result of the event but was treated with antibiotics. Further info was not made available at this time. The sample is available for an eval.
Patient Sequence No: 1, Text Type: D, B5
[9115237]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2011-00009 |
| MDR Report Key | 2066179 |
| Report Source | 05,06 |
| Date Received | 2011-03-29 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-03-04 |
| Date Facility Aware | 2011-03-04 |
| Report Date | 2011-03-29 |
| Date Reported to Mfgr | 2011-03-04 |
| Date Mfgr Received | 2011-03-04 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2011-08-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MARGARET CHARETTE, RN |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSA F4 (HF/PS/0.65/L) |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2011-03-29 |
| Model Number | NA |
| Catalog Number | 0500161A |
| Lot Number | 09PU04005 |
| ID Number | NA |
| Device Expiration Date | 2012-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-29 |