UNKNOWN
Received Jan 27, 2017 · Event occurred Nov 23, 2016
Report 3007420694-2017-00020 · MDR key 6282949
Device
Generic name
Unknown
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
THIS REPORT IS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ENCLOSED IS OUR INFORMATION FOR A COMBINED INITIAL AND FINAL MEDWATCH REPORT, FORM 3500A. WE ARE REPORTING THIS INCIDENT TO ENSURE THAT WE FULLY COMPLY WITH MEDWATCH REPORTING REQUIREMENTS. ARJOHUNTLEIGH HAS RECEIVED AN INFORMATION ABOUT A REPORTABLE EVENT ON THE PRODUCT WHICH WAS NOT MANUFACTURED OR IMPORTED BY ARJOHUNTLEIGH. WE ARE FORWARDING THE INFORMATION ABOUT THIS ADVERSE EVENT FOLLOWING THE REGULATION UNDER 21 C.F.R 803.22.2(B). PLEASE NOTE THAT DESPITE OUT BEST EFFORT ARJOHUNTLEIGH DID NOT MANAGE TO IDENTIFY THE ORIGINAL MANUFACTURER NOR A BRAND NAME OF INVOLVED DEVICE. - ATTACHMENT: [COVER LETTER (B)(4).PDF]
Description of Event or Problem
ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED ON A NON-ARJOHUNTLEIGH DEVICE. A FEMALE PATIENT WITH MULTIPLE SCLEROSIS, WHO WAS A WHEELCHAIR USER HAS SLIPPED IN A BATHTUB, DESPITE THE HELP OF TWO CAREGIVERS SUPPORTING HER. THE EVENT TOOK PLACE AT THE NURSING HOME. THE PATIENT HAS A CEREBRAL PALSY ON ONE ENTIRE SIDE OF THE BODY. AS A RESULT SHE SUFFERED FROM A LEG FRACTURE WHICH HAD TO BE FOLLOWED BY THE SURGERY AT (B)(6) HOSPITAL WHICH TOOK PLACE ON (B)(6) 2016.