FDA Adverse Event
Injury
Summary report: N
HUBLESS SILICONE FLAT DRAIN
MDR report key: 4435900
·
Received January 16, 2015
Report
- Report Number
- 1018233-2015-00009
- Event Type
- Injury
- Date Received
- January 16, 2015
- Date of Event
- November 11, 2014
- Report Date
- December 22, 2014
- Manufacturer
- PRODUCTOS PARA EL CUIDADO DE LA SALUD
- Product Code
- GBY
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE REMOVAL OF THE DEVICE, THE WHITE PIECE HAD BECOME DISCONNECTED FROM THE CLEAR TUBING AND REMAINED INSIDE THE PATIENT. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM WHERE SHE UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PIECE LEFT BEHIND. THE FACILITY REPORTS THE TUBING WAS NOT BROKEN BUT CAME APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40433 | HUBLESS SILICONE FLAT DRAIN | GBY | PRODUCTOS PARA EL CUIDADO DE LA SALUD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |