MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for CARDINAL HEALTH 09-6551D manufactured by Cardinal Health 200, Llc.
[108806059]
Patient Sequence No: 1, Text Type: N, H10
[108806060]
Patient called provider's office to report they believed their nexplanon implant was broken. Provider examined the patient in office and the device did appear to be broken. After discussion with the patient, the patient wished to have the broken rod removed and replaced with a new one. Procedure was completed uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7530553 |
| MDR Report Key | 7530553 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-30 |
| Report Date | 2018-05-08 |
| Date Reported to FDA | 2018-05-08 |
| Date Reported to Mfgr | 2018-05-08 |
| Date Added to Maude | 2018-05-21 |
| 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 | CARDINAL HEALTH |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2018-05-21 |
| Model Number | 09-6551D |
| Catalog Number | 09-6551D |
| Lot Number | 164280 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |