FDA Adverse Event
Malfunction
Summary report: N
J-VAC RESERVOIR
MDR report key: 1812727
·
Received August 13, 2010
Report
- Report Number
- 2210968-2010-00918
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 13, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- KOG
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2010. A RESERVOIR WAS CONNECTED TO A DRAIN AND FUNCTIONED PROPERLY UPON FIRST ACTIVATION. ON (B)(6) 2010, THE LOCKING PLATE OF THE RESERVOIR WAS TOO TIGHT TO BE LOCKED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-VAC RESERVOIR | WOUND DRAINAGE SYSTEM | KOG | ETHICON, INC. | NA | JT7122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |