FDA Adverse Event
Other
Summary report: N
MAMMOGRAPHY POSITIONING CHAIR
MDR report key: 183671
·
Received August 20, 1998
Report
- Report Number
- 2424102-1998-00003
- Event Type
- Other
- Date Received
- August 20, 1998
- Date of Event
- July 17, 1998
- Report Date
- August 14, 1998
- Manufacturer
- TREX MEDICAL CORP./BENNETT DIVISION
- Product Code
- INM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
MAMMO CHAIR WAS IN FLAT POSITION WHILE PT LYING ON HER RIGHT SIDE. DR ASKED HER TO ROLL ONTO HER BACK. WHEN SHE DID THIS THE HEAD SECTION OF THE CHAIR MOVED TO TRENDELENBERG POSITION KNOCKING DR BACKWARD INTO THE LEAD SHIELDING AND HIT HIS HEAD ON THE LEAD SHIELD TO CAUSE MINOR LACERATION. THE PT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOGRAPHY POSITIONING CHAIR | POSITIONING CHAIR | INM | TREX MEDICAL CORP./BENNETT DIVISION | M-PCH | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |