FDA Adverse Event
Malfunction
Summary report: N
BLAKE DRAIN
MDR report key: 1901059
·
Received November 10, 2010
Report
- Report Number
- 2210968-2010-01483
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 11, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- KOG
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - TROCAR SLEEVE DIFFICULT TO REMOVE: 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2010 AND A DRAIN WAS PLACED. PRIOR TO PLACING THE DRAIN, THE SURGEON STATED THE PROTECTIVE SHEATH WAS EXTREMELY DIFFICULT TO REMOVE FROM THE TROCAR, BUT WAS ABLE TO EVENTUALLY REMOVE IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLAKE DRAIN | WOUND DRAINAGE SYSTEM | KOG | ETHICON, INC. | NA | W00026534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |