FDA Adverse Event
Other
Summary report: N
ASP AUTOMATIC ENDOSCOPIC REPROCESSOR (AER)
MDR report key: 616480
·
Received June 23, 2005
Report
- Report Number
- 2084725-2005-00246
- Event Type
- Other
- Date Received
- June 23, 2005
- Date of Event
- December 22, 2004
- Report Date
- January 17, 2005
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- KOG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORT FROM USER FACILITY INDICATED THAT PT EXPERIENCED IRRITATION OF THE BOWEL. PT HAD CRAMPS AND DIARRHEA DESCRIBED AS COLITIS THAT LASTED FOR ONE DAY FOLLOWING ENDOSCOPY. PT IS CURRENTLY WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASP AUTOMATIC ENDOSCOPIC REPROCESSOR (AER) | AUTOMATIC ENDOSCOPE | KOG | ADVANCED STERILIZATION PRODUCTS | 20301 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |