MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-01 for UNKNOWN ENDO GIA INSTRUMENT manufactured by Covidien, Formerly Us Surgical A Divison.
[58921214]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[58921215]
According to the reporter, following a hysteroscopy, the patient returned to the office (and then to the emergency room) with significant bleeding. The patient was thought to have been diagnosed with an atrial venous malfunction and/or a uterine aneurism. The doctor stated that she used methergine post surgery and that this was sufficient to control the bleeding. The patient is currently well. There was no specified device malfunction. Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2016-01142 |
| MDR Report Key | 6069296 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-01 |
| Date of Report | 2016-10-12 |
| Date Mfgr Received | 2016-10-12 |
| Date Added to Maude | 2016-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ENDO GIA INSTRUMENT |
| Generic Name | NOT AVAILABLE |
| Product Code | KCT |
| Date Received | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-01 |