MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2010-06-02 for COOK ECHOTIP AMNIOCENTESIS NEEDLE J-DAN-220901 manufactured by Cook Urological, Inc..
[1561641]
The doctor at (b)(6) swapped to our needles from bd in (b)(6) - same needle gauge and size. Since the swap, he has had two miscarriages - the patient details are as follows:((b)(6) 2010): average body weight. Nuchal scan reading 4. 4 multiple. Came in (b)(6) with bleeding - later ruptured membrane and iud (b)(6). I have tried to get as much information as possible. The doctor is the lone practitioner doing amnios at (b)(6). He has changed nothing and had no previous cases of miscarriage in 2 years.
Patient Sequence No: 1, Text Type: D, B5
[8585476]
The devices will not be returned due to them being discarded, a proper evaluation will not be performed. Additional information is being requested, upon receipt of the information it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[6365924]
The doctor at (b)(6) swapped to our needles from bd in (b)(6) - same needle gauge and size. Since the swap he has had two miscarriages - the patient details are as follows: patient 2 ((b)(6) 2010): average body weight, (b)(6). Nuchal scan reading normal. As older patient had downs risk of 1/38. Came in (b)(6) with miscarriage. I have tried to get as much information as possible. The doctor is the lone practitioner doing amnios at (b)(6). He has changed nothing and had no previous cases of miscarriage in 2 years. "
Patient Sequence No: 2, Text Type: D, B5
[13518432]
The devices will not be returned due to them being discarded, a proper evaluation will not be performed. Additional information is being requested, upon receipt of the information it will be forwarded.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 1825146-2010-00021 |
| MDR Report Key | 1759977 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2010-06-02 |
| Date of Event | 2010-04-24 |
| Date Mfgr Received | 2010-05-11 |
| Date Added to Maude | 2010-07-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK ECHOTIP AMNIOCENTESIS NEEDLE |
| Generic Name | HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) |
| Product Code | HIO |
| Date Received | 2010-06-02 |
| Model Number | NA |
| Catalog Number | J-DAN-220901 |
| Lot Number | U1922861 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-02 | |
| 2 | 0 | 2010-06-02 |