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 |