TOROSA SALINE TESTICULAR LARGE
Received Mar 24, 2016 · Event occurred Mar 2, 2016
Report 2125050-2016-00034 · MDR key 5523980
Device
Generic name
Testicular Prosthesis,
Manufacturer
Coloplast A/sModel number
5206502400Catalog number
5206502400
Lot number
4859687
Product problems
- Material Erosion
Patient
Not reported
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE, SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PRESENTED TO A COMMUNITY HOSPITAL AND THE TESTICULAR IMPLANT HAD ERODED. IT WAS REMOVED IN THE EMERGENCY DEPARTMENT.
Additional Manufacturer Narrative
A LARGE TOROSA SALINE FILLED TESTICULAR WAS RECEIVED FOR EVALUATION. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENT MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION, QA DID NOT PERFORM TESTING OR MICROSCOPIC EXAMINATION. BASED ON THE INFORMATION PROVIDED QA ACCEPTS, THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. IF ADDITIONAL INFORMATION IS RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PRESENTED TO A COMMUNITY HOSPITAL AND THE TESTICULAR IMPLANT HAD ERODED. IT WAS REMOVED IN THE EMERGENCY DEPARTMENT.