FDA Adverse Event
Injury
Summary report: N
THERMACHOICE
MDR report key: 1639425
·
Received March 22, 2010
Report
- Report Number
- 2210968-2010-00234
- Event Type
- Injury
- Date Received
- March 22, 2010
- Date of Event
- January 8, 2010
- Report Date
- February 24, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- MKN
- PMA / PMN Number
- P970021
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B) (6) 2010. IMMEDIATELY AFTER THE PROCEDURE, THE PT COMPLAINED OF CRAMPING. ON (B) (6) 2010, SHE RETURNED TO THE OFFICE FOR SEVERE CRAMPING AND A CERVICAL CULTURE WAS PERFORMED. THE PT RETURNED AGAIN ON (B) (6) 2010 AND (B) (6) 2010 STILL COMPLAINING OF CRAMPING, AND WAS DIAGNOSED WITH A BURN/NECROTIC CERVIX AND WAS PRESCRIBED ANTIBIOTICS. THE PT IS STILL UNDER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMACHOICE | CATHETER, BALLOON, TRANSCERVICAL | MKN | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |