FDA Adverse Event
Injury
Summary report: N
NEW IMAGE DRAINABLE TOUCH W/LOCK'N ROLL
MDR report key: 1833572
·
Received September 3, 2010
Report
- Report Number
- 1119193-2010-00003
- Event Type
- Injury
- Date Received
- September 3, 2010
- Date of Event
- August 8, 2010
- Report Date
- September 9, 2010
- Manufacturer
- HOLLISTER INCORPORATED
- Product Code
- EXB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL IS ONGOING.
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE USER'S OSTOMY POUCH WHEN THE PLASTIC RING SEPARATED FROM THE POUCH. AT THE TIME THE LEAKAGE OCCURRED, THE USER WAS UNABLE TO GET TO A WASHROOM TO CLEAN THE AREA. SHE DEVELOPED A WOUND ON HER SKIN WHICH BECAME INFECTED RESULTING IN HOSPITALIZATION FROM (B)(6)2010 THRU (B)(6)2010. THE INFECTION WAS DIAGNOSED AS CELLULITIS AND IT WAS 8CM IN DIAMETER. SHE RECEIVED IV ANTIBIOTIC THERAPY AND WAS DISCHARGED WITH IV VANCOMYCIN AND NYSTATIN/CORTISONE MIX PASTE TO APPLY TO THE AFFECTED AREA. THE IV THERAPY WAS EXPECTED TO BE CONTINUED UNTIL (B)(6)2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEW IMAGE DRAINABLE TOUCH W/LOCK'N ROLL | NEW IMAGE DRAINABLE POUCH | EXB | HOLLISTER INCORPORATED | 18182 | OD122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization |