MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for SUTURE manufactured by Covidien.
[90862370]
Patient Sequence No: 1, Text Type: N, H10
[90862371]
Pt. Arrived to the (b)(6) center for retrieval of a foreign body from her left breast retroareolar area. Sequence of events: ultrasound left breast indication: left nipple discharge. -recommended left ductogram. Surgical consult. Twelve days later: ductogram- unable to perform left ductogram, no nipple discharge. Surgical follow-up with the patient's breast surgeon. Two days later: left breast mri performed. Impression; nonspecific tiny focus of enhancement within the nipple. There is no additional abnormality seen in the left breast to account for the patient's left nipple inversion. Recommended surgical consultation. Eight days later: left nipple exploration and central duct excision performed in the operating room. About 11 months later: left breast digital mammogram- a new 1. 3x0. 5 mm radiopaque foreign body was found within the left retroareolar breast which was not present on prior study. The findings were discussed with the patient's surgeon. About 1 month later: stereotactic with specimen of the left breast was ordered. Successful stereotactically guided retrieval of a radiopaque foreign body within the retroareolar left breast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6995880 |
| MDR Report Key | 6995880 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-06-27 |
| Report Date | 2017-09-28 |
| Date Reported to FDA | 2017-09-28 |
| Date Reported to Mfgr | 2017-09-28 |
| Date Added to Maude | 2017-11-02 |
| 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 | PATIENT |
| 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 | SUTURE |
| Generic Name | SUTURE KIT |
| Product Code | OVN |
| Date Received | 2017-11-02 |
| ID Number | 3-0 POLYSORB |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |