MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-27 for J-VAC*RESV. 150 ML 2177 manufactured by Ethicon Inc..
[177192550]
(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. The following information was requested and the following was obtained: did the reservoir inflate quickly upon activation? Yes. Was leakage detected? If so, where? No further information is available. Or was there a failure of the locking plate mechanism due to which the reservoir swelled immediately? No further information is available. No further information will be provided. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[177192551]
It was reported a patient underwent a laparoscopic cholecystectomy on (b)(6) 2020 and a reservoir was used. After lifting the bottom flap, the reservoir swelled immediately, thus, suction could not be done. The reservoir was reconnected to the drain, but the same issue occurred. So, the reservoir was replaced to another one, then, suction could be done after bending up the bottom flap. Further details are not provided. No sample will be returned. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00731 |
| MDR Report Key | 9634151 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-01-27 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-FLEXTRONICS MEDICAL |
| Manufacturer Street | 1659 GAILES BLVD |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-VAC*RESV. 150 ML |
| Generic Name | WOUND DRAINAGE SYSTEM |
| Product Code | KOG |
| Date Received | 2020-01-27 |
| Catalog Number | 2177 |
| Lot Number | JT8925 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |