MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-31 for ADHERUS AUTOSPRAY DURAL SEALANT NUS-006 manufactured by Stryker Cmf Us.
| Report Number | 3005920920-2019-00002 |
| MDR Report Key | 8845656 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-31 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2019-07-31 |
| 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. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER CMF US |
| Manufacturer Street | MICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADHERUS AUTOSPRAY DURAL SEALANT |
| Generic Name | IMPLANT |
| Product Code | NQR |
| Date Received | 2019-07-31 |
| Catalog Number | NUS-006 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CMF US |
| Manufacturer Address | MICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200 PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-31 |