MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-10-12 for FEMORAL INTRODUCER SHEATH AND HEMOSTASIS 16-06-01-S manufactured by Morris Innovative, Inc..
[16041813]
Bleeding occurred around sheath, unable to achieve hemostasis with fish device. Femostop was applied to pt. Hematoma approx the size of a cantaloupe, dissolved away. Pt was initially reported as okay. Ptt was high, thrombocytopenia (not device related). Pt passed away the evening of (b)(6) 2010; procedure related. Pt had disseminated intravascular coagulation (dic). Not device related. Physician stated, pt was not in good condition before procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004534947-2010-00004 |
| MDR Report Key | 1906077 |
| Report Source | 05,06,07 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-05 |
| Date Mfgr Received | 2010-10-05 |
| Device Manufacturer Date | 2010-08-31 |
| Date Added to Maude | 2010-11-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 907 W 2ND STREET |
| Manufacturer City | BLOOMINGTON IN 47403 |
| Manufacturer Country | US |
| Manufacturer Postal | 47403 |
| Manufacturer Phone | 8123550450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL INTRODUCER SHEATH AND HEMOSTASIS |
| Generic Name | FISH |
| Product Code | OEX |
| Date Received | 2010-10-12 |
| Model Number | 16-06-01-S |
| Catalog Number | 16-06-01-S |
| Lot Number | 3498 |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORRIS INNOVATIVE, INC. |
| Manufacturer Address | BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-10-12 |