MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-30 for MILLEX GS * SLGSV255F manufactured by Millipore Corp..
[22173631]
Rptr works for a mfr that uses the filters in their processing of f18 fdg, which is used during positron emission tomography. The co's end product was determined as pyrogenic for a period of several months. After research and testing, the cause of the pyrogenic end product was determined to be filters from the reported lot number. The rptr states that the co informed all of their sites to stop using the filters from that lot. The rptr claims that the firm has used these filters in their mfg process for "some time", and this event has been isolated to the lot number in question. Since the rptr's product is tested thoroughly prior to distribution, all the products affected were not distributed for use. No pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016227 |
| MDR Report Key | 221461 |
| Date Received | 1999-04-30 |
| Date of Report | 1999-04-30 |
| Date Added to Maude | 1999-05-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLEX GS |
| Generic Name | MILLIPORE FILTER |
| Product Code | JRL |
| Date Received | 1999-04-30 |
| Model Number | * |
| Catalog Number | SLGSV255F |
| Lot Number | R8EM78710 |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214754 |
| Manufacturer | MILLIPORE CORP. |
| Manufacturer Address | 80 ASHBY RD. BEDFORD MA 01730 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-30 |