FDA Adverse Event
Other
Summary report: N
CARENDO
MDR report key: 2695271
·
Received August 8, 2012
Report
- Report Number
- 9611530-2012-00122
- Event Type
- Other
- Date Received
- August 8, 2012
- Date of Event
- July 19, 2012
- Report Date
- July 19, 2012
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR ARJO (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED TO AHUS QA BY SALES THAT A CARENDO SEAT HAD CAUSED SKIN TEARS ON A PT DUE TO JAGGED EDGES. THE SEAT WAS REPLACED BUT WHEN THE PT WAS TAKING A SHOWER, THEIR WOUNDS OPENED UP AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARENDO | SHOWER SYSTEMS | FSA | ARJO HOSPITAL EQUIPMENT AB | BIB2003-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other |