COMPEED NOS
Received Sep 15, 2021
Report 3014660808-2021-00001 · MDR key 12474327
Device
Generic name
Compeed
Manufacturer
Coloplast Hungary KftProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THIS SERIOUS SPONTANEOUS INCIDENT REPORT WAS RECEIVED ON 24 AUG 2021 FROM A PATIENT IN THE UNITED STATES VIA COMPEED (B)(6) PAGE ((B)(4)). THIS REPORT INVOLVED A PATIENT WITH UNSPECIFIED AGE AND GENDER WITH NO REPORTED MEDICAL HISTORY OR CONCOMITANT MEDICATION. ON UNSPECIFIED DATE, THE PATIENT "WORE ONE OF COMPEED BANDAGES ON A HIKE" WITH NO FURTHER INFORMATION. ON UNSPECIFIED DATE, UNSPECIFIED TIME LATENCY FOLLOWING THE APPLICATION OF THE DEVICE, THE PATIENT REPORTED THAT HIS/HER "FOOT HAD TO BE AMPUTATED". AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS NOT RECOVERED. NO OTHER INFORMATION WAS REPORTED AND NO FURTHER INFORMATION COULD BE OBTAINED AS NO CONTACT DETAILS WERE PROVIDED.
Additional Manufacturer Narrative
FOOT AMPUTATION IS UNLISTED FOR COMPEED. THE LACK OF RELEVANT INFORMATION REGARDING THE PATIENT'S MEDICAL CONDITION, THE PRODUCT, THE CIRCUMSTANCES OF THE EVENT AND THE CLINICAL COURSE DOES NOT PERMIT A PROPER ASSESSMENT OF THE CAUSAL RELATIONSHIP BETWEEN COMPEED AND THE OCCURRENCE OF THE FOOT AMPUTATION. ACCORDINGLY, THIS CASE IS NOT ASSESSABLE. THIS ASSESSMENT IS FINAL AS NO FURTHER INFORMATION IS EXPECTED.