MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-08-21 for JACKSON-PRATT CHANNEL DRAIN JP-2189 11003811580CR manufactured by Degania Silicone Ltd.
| Report Number | 8030107-2019-00010 |
| MDR Report Key | 8914878 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-08-21 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-06-07 |
| Date Mfgr Received | 2019-06-10 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-08-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KATIA KAYAM |
| Manufacturer Street | DEGANIA BET |
| Manufacturer City | DEGANIA BET, JORDAN VALLEY 1513000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 1513000 |
| Manufacturer G1 | DEGANIA SILICONE LTD |
| Manufacturer Street | DEGANIA BET |
| Manufacturer City | DEGANIA BET, 1513000 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 1513000 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 8030107-06/28/2019-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON-PRATT CHANNEL DRAIN |
| Generic Name | SILICONE FLUTED 15FR DRAIN |
| Product Code | GCB |
| Date Received | 2019-08-21 |
| Model Number | JP-2189 |
| Catalog Number | 11003811580CR |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGANIA SILICONE LTD |
| Manufacturer Address | DEGANIA BET DEGANIA BET, 1513000 IS 1513000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-21 |