πŸ› Central Drugs Standard Control Organisation Β· MvPI India Β· CDSCO

Suspected Medical Device Adverse Event Reporting Form

Materiovigilance Programme of India β€” VOLUNTARY reporting by Healthcare Professionals Β· CDSCO Helpline: 1800-11-0019

Generating reference…
Form completion0%
A
Patient Information *
Patient identity is held in strict confidence β€” no full name required
B
Suspected Medical Device *
Include all identifiers available β€” batch/lot or serial number is essential
14. Device Usage Dates
15. Single-use Device?
C
Adverse Event Description *
Describe the event, seriousness, and outcome
21. Seriousness of the event
22. Patient Outcome *
23. Action Taken
πŸ“Ž
Upload Documents & Evidence
Device label Β· Photos Β· Investigation reports Β· Discharge summary Β· Operative notes
🏷 Device label / package πŸ“· Device photos πŸ“‹ Operative notes πŸ§ͺ Lab / pathology reports 🩻 Imaging reports πŸ“„ Discharge summary
πŸ“Ž

Click to browse files or drag & drop here

JPG Β· PNG Β· PDF Β· Max 10 MB per file Β· Up to 5 files

β„Ή
Additional Information
Any other information relevant to this materiovigilance report
D
Reporter Details *
Reporter identity is confidential β€” submission does not imply legal liability
πŸ”’
Patient identity is held in strict confidence. Submission does not constitute an admission that medical personnel or manufacturer caused the event. Reports are forwarded to AMC β†’ CDSCO MvPI National Coordination Centre.
Scroll to Top