inforMED
MalfunctionILM

MAILBU/SOVEREIGN (INCL DIGNITY)

Received Jul 5, 2013

Report 9611530-2013-00080 · MDR key 3221100

Device

Product problems

  • Defective Component

Patient

Not reported

  • Laceration(s)

Narrative

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR, ARJO (B)(4), ON BEHALF OF THE IMPORTER, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

Description of Event or Problem

(B)(4).