MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-09 for PNEUMOLINER WA90500US manufactured by Advanced Surgical Concepts Ltd..
| Report Number | 9616720-2019-00001 |
| MDR Report Key | 8771649 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2019-06-12 |
| Date Added to Maude | 2019-07-09 |
| 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. EDWARD HYLAND |
| Manufacturer Street | UNIT 1&4, SUNNYBANK CENTER UPPER DARGLE ROAD |
| Manufacturer City | BRAY, COUNTY WICKLOW A98 E339 |
| Manufacturer Country | EI |
| Manufacturer Postal | A98 E339 |
| Manufacturer G1 | DIELECTRICS INC. |
| Manufacturer Street | 300 BURNETT ROAD |
| Manufacturer City | CHICOPEE MA 01020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMOLINER |
| Generic Name | LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM |
| Product Code | PMU |
| Date Received | 2019-07-09 |
| Model Number | WA90500US |
| Catalog Number | WA90500US |
| Lot Number | 113202 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED SURGICAL CONCEPTS LTD. |
| Manufacturer Address | UNIT 1&4, SUNNYBANK CENTER UPPER DARGLE ROAD BRAY, A98 E339 EI A98 E339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-07-09 |