MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-02-08 for COOK AMNIOCENTESIS TRAY J-DANY-201201-C2 manufactured by Cook Urological, Inc..
[22077353]
Facility has had three miscarriages and infections in one week. Facility has been using these sets for a few years with no problems until now. Facility has not changed personnel or equipment. Could it be the betadine or needle?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825146-2005-00001 |
| MDR Report Key | 572271 |
| Report Source | 05,06 |
| Date Received | 2005-02-08 |
| Date Added to Maude | 2005-02-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 1100 WEST MORGAN STREET |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK AMNIOCENTESIS TRAY |
| Generic Name | * |
| Product Code | HIO |
| Date Received | 2005-02-08 |
| Model Number | NA |
| Catalog Number | J-DANY-201201-C2 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 562146 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | 1100 WEST MORGAN ST. SPENCER IN 47460 US |
| Baseline Brand Name | COOK AMNIOCENTESIS TRAY |
| Baseline Generic Name | AMNIOCENTESIS TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | J-DANY-201201-C2 |
| Baseline ID | NA |
| Baseline Device Family | SAMPLER, AMNIOTIC FLUID |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K892846 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-08 |