MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-10-16 for NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE 0700003000 manufactured by Stryker Instruments-kalamazoo.
[28476104]
There is no alleged failure of the unit and the device is not available for evaluation. Legal case.
Patient Sequence No: 1, Text Type: N, H10
[28476145]
On or about (b)(4) 2015 stryker received notice that a neptune 1 silver device was used on a patient's wound drain following a posterior lumbar interbody fusion from l3 through s1 on (b)(6) 2011. The patient lost 1400 ccs of blood in under one minute. The patient lost blood pressure and a pulse, and required emergent resuscitation leading to a significant anoxic shock to the brain and organs. There are no allegations the product failed to perform as designed. Stryker is unable to ascertain whether or not one of its products was actually used and will not be able to obtain the product except within the litigation process, if at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-03815 |
| MDR Report Key | 5155963 |
| Report Source | OTHER |
| Date Received | 2015-10-16 |
| Date of Report | 2015-09-18 |
| Date of Event | 2011-12-14 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-10-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2015-10-16 |
| Catalog Number | 0700003000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-10-16 |