| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CONVEEN CONTOUR,600/45,STERILE | URINE COLLECTION BAG FOR EXTERNAL USE. | COLOPLAST A/S | FAQ | 0517102004 | 0517102004 | 5098477 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-09 | 0 | 1. O |
Patient 1
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.
Patient 1
ACCORDING TO THE AVAILABLE INFORMATION, THE DAUGHTER OF THE (B)(6) FEMALE USER HAS INFORMED A COLLEAGUE OF DEPARTMENT "CONSUMER SALES", URINE COULD NOT FLOW INTO THE BAG, IT WAS BLOCKED ON THE LEVEL OF THE INLET VALVE. THE CONVEEN CONTOUR,600/45,STERILE BAG WAS ATTACHED TO AN URO-STOMA BAG FOR ABOUT 12 HOURS AS WELL AT NIGHT. NEXT MORNING THE DAUGHTER HAS NOTICED, THE BED OF HER MOTHER WAS WET, THE URO-STOMA BAG WAS ALMOST FULL AND ONLY FEW URINE WAS IN THE UPPER AREA OF THE CONVEEN BAG. AS SHE HAS NOTICED THE URINE APPEARS VERY DARK, SHE HAS CALLED AN AMBULANCE WHO HAS BROUGHT HER MOTHER TO A HOSPITAL. THE DOCTOR HAS DETECTED SOME BLOOD IN THE URINE.. THE DAUGHTER SAYS, "BLOOD WAS COMING FROM THE BLADDER FOR 2 DAYS". THE DOCTOR DID NOT PRESCRIBED ANY MEDICINE AND THE USER WAS DISCHARGED FROM THE HOSPITAL FEW HOURS LATER. THE PATIENT IS WELL. THE DAUGHTER CLAIMS, THE BLOOD IN THE URINE WAS CAUSED BY THE REFLUX, AS THE URINE COULD NOT FLOW INTO THE CONVEEN BAG. WE DO NOT KNOW, WHETHER THE DOCTOR HAS EXPRESSED THE SAME. CORRECTIVE AND ADDITIONAL INFORMATION: DUE TO MISUNDERSTANDING AND POSSIBLE WRONGLY PROVIDED INFORMATION OF THE DAUGHTER. THE PATIENT DOES NOT HAVE AN UROSTOMY BUT A NEPHROSTOMY, SO THE CONVEEN CONTOUR,600/45,STERILE WAS NOT CONNECTED TO A UROSTOMY-BAG BUT CONNECTED TO A NEPHROSTOMA-CATHETER (PRODUCT NAME/PRODUCER NOT KNOWN). THE ARE NO SAMPLES AVAILABLE.
Patient 1
AS NO PRODUCTS WERE RECEIVED FOR TESTING IT IS NOT POSSIBLE TO CHECK IF THE PRODUCTS IN QUESTION ARE IN COMPLIANCE WITH NORMS OR WHETHER THE PROBLEM REPORTED WAS CAUSED BY A PRODUCTION ERROR. NO ADDITIONAL COMPLAINTS REGISTERED REGARDING THIS LOT NUMBER. A RECHECK OF THE PRODUCT DOCUMENTATION FOR THIS LOT NUMBER DID NOT REVEAL ANY NORM DEVIATION THAT COULD BE RELATED TO THE COMPLAINT. BECAUSE THIS IS A REPORTABLE COMPLAINT, A CAPA (B)(4) IS INITIATED ON 2016-11-24 TO FOLLOW UP THE INVESTIGATION.