FDA Adverse Event
Injury
Summary report: N
GREAT RIVER MEDICAL CENTER D & C VAG HYST PACK
MDR report key: 8772727
·
Received July 8, 2019
Report
- Report Number
- MW5087959
- Event Type
- Injury
- Date Received
- July 8, 2019
- Date of Event
- June 28, 2019
- Report Date
- July 3, 2019
- Manufacturer
- AMERICAN CONTRACT SYSTEMS
- Product Code
- OHD
- UDI-DI
- 00191072042361
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
HAIR FOUND IN CUSTOM D & C VAG HYST PACK WHEN OPENED. WAS ON TOP OF PREP TRAY. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559884 | GREAT RIVER MEDICAL CENTER D & C VAG HYST PACK | GYNECOLOGICAL LAPAROSCOPIC KIT | OHD | AMERICAN CONTRACT SYSTEMS | 898191 | 00191072042361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |