MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for COLOPLAST 52081 manufactured by Coloplast A/s.
[105782588]
Patient Sequence No: 1, Text Type: N, H10
[105782589]
Product piece on end (tip) of manipulation was missing. We were able to use the instrument without the piece for this procedure. Product had patient contact but no patient harm. Product was saved and can be returned to the vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7439415 |
| MDR Report Key | 7439415 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-02-06 |
| Report Date | 2018-04-10 |
| Date Reported to FDA | 2018-04-10 |
| Date Reported to Mfgr | 2018-04-10 |
| Date Added to Maude | 2018-04-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | COLOPLAST |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLA |
| Product Code | PAJ |
| Date Received | 2018-04-18 |
| Model Number | 52081 |
| Lot Number | 5924774 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | 1601 WEST RIVER ROAD N. MINNEAPOLIS MN 55418 US 55418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-18 |