FDA Adverse Event
Malfunction
Summary report: N
BASIC GYN ROBOTICS DRAPE
MDR report key: 14043251
·
Received April 6, 2022
Report
- Report Number
- MW5108814
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- April 4, 2022
- Report Date
- April 4, 2022
- Manufacturer
- MEDLINE INDUSTRIES, LP - SPT
- Product Code
- MLS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MEDLINE INDUSTRIES BASIC GYN ROBOTICS DRAPE HAD A 3 INCH SLIT UPON OPENING. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1013053 | BASIC GYN ROBOTICS DRAPE | LABOR AND DELIVERY KIT | MLS | MEDLINE INDUSTRIES, LP - SPT | CMPJ05907 | 211BF178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female |