FDA Adverse Event
Malfunction
Summary report: N
ROLLATOR 9153651315
MDR report key: 4447939
·
Received January 23, 2015
Report
- Report Number
- 1525712-2015-00632
- Event Type
- Malfunction
- Date Received
- January 23, 2015
- Report Date
- January 15, 2015
- Manufacturer
- DOLOMITE AB
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - - INITIAL MFG REPORT # 1525712-2015-000632 WAS SUBMITTED TO THE FDA ON (B)(4) 2015 INDICATING THE MANUFACTURER AS UNKNOWN. THE ACTUAL MANUFACTURER IS DOLOMITE AB. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: (B)(4).
Description of Event or Problem · 1
ORIGINAL ORDER (B)(4) PIN SNAPPED DURING AVERAGE USE. CLIENT IS UNDER WEIGHT LIMIT. PICTURE ATTACHED, PLEASE HOLD FOR NIC ONG UPON APPROVAL.
Description of Event or Problem · 1
ORIGINAL ORDER (B)(4)/ INVOICE (B)(4)/ SERIAL NUMBER (B)(4)/ PIN SNAPPED DURING AVERAGE USE. CLIENT IS UNDER WEIGHT LIMIT. PICTURE ATTACHED, PLEASE HOLD FOR NIC ONG UPON APPROVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56456 | ROLLATOR 9153651315 | WALKER, MECHANICAL | IOR | DOLOMITE AB | 12030-44-86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |