MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for COAPTITE M006890300 manufactured by Merz North America, Inc..
[111199937]
Patient Sequence No: 1, Text Type: N, H10
[111199939]
The coaptite implant was hard to push through syringe and needle. Staff opened a second syringe with same lot number and then a third syringe with a different lot number. They all had the same issue. Staff opened the second needle and had the same issue.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 7604942 |
MDR Report Key | 7604942 |
Date Received | 2018-06-15 |
Date of Report | 2018-06-06 |
Date of Event | 2018-05-23 |
Report Date | 2018-06-06 |
Date Reported to FDA | 2018-06-06 |
Date Reported to Mfgr | 2018-06-06 |
Date Added to Maude | 2018-06-15 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | COAPTITE |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Product Code | LNM |
Date Received | 2018-06-15 |
Catalog Number | M006890300 |
Lot Number | 100103908 |
Operator | PHYSICIAN |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MERZ NORTH AMERICA, INC. |
Manufacturer Address | 6501 SIX FORKS ROAD RALEIGH NC 27615 US 27615 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-06-15 |