ESTEEM SYNERGY
Received Jun 8, 2018
Report 9618003-2018-00386 · MDR key 7584267
Device
Generic name
Appliance, Colostomy, Disposable
Manufacturer
Convatec Dominican Republic IncModel number
403986Product problems
- Malposition of Device
- Malposition of Device
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
THE DISTRIBUTOR REPORTED THE SKIN BARRIER STARTER HOLE WAS DEFECTIVE (OFF CENTER). THE DEVICE WAS NOT USED. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.