DUOLOCK TAIL CLSR CURVED TAN
Received Mar 25, 2016
Report 1000317571-2016-00031 · MDR key 5527245
Device
Generic name
Appliance, Colostomy, Disposable
Manufacturer
Convatec LimitedModel number
SRA8280Lot number
5E03205
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Irritation
- Discomfort
- Skin Irritation
- Discomfort
Narrative
Additional Manufacturer Narrative
EXPIRATION DATE: 05/2020. MANUFACTURING DATE: 05/2015. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: TWO CASES ASSOCIATED WITH THIS COMPLAINT. A SEPARATE FDA FORM 3500A HAS BEEN COMPLETED FOR THE UNKNOWN NUMBER OF AFFECTED PRODUCTS WITH MULTIPLE POSSIBLE LOTS NUMBERS ASSOCIATED WITH THIS COMPLAINT. (B)(4).
Description of Event or Problem
IT WAS REPORTED BY THE END USER THAT THE TAIL CLIPS DIG AND IRRITATE HER FLESH IN THE AREA OF THE ABDOMEN WHERE THE CLIP RESTS/DIGS IN. IT WAS ALSO REPORTED THAT THIS HAS OCCURRED WITH OTHER SIMILAR PRODUCTS FOR YEARS.