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 2020-02-12 for J-VAC*RESV. 150 ML 2177 manufactured by Ethicon Inc..
[188536077]
(b)(4). Attempts have been made to retrieve the device. 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
[188536078]
It was reported a patient underwent an unknown surgery on an unknown date and a reservoir was used. During surgery, negative pressure could not be applied. Further details are not provided. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01132 |
| MDR Report Key | 9700306 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-17 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | 2177 |
| Lot Number | JU0034 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-12 |