N
Patient 1
A MODEL, UDI OR MANUFACTURER LOT CODE WERE NOT PROVIDED. WITH NO MEANS TO DETERMINE THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.
MAUDE MDR 9632295
- MDR report key
- 9632295
- Report number
- 3011109575-2020-00439
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-12-01
- Date received
- 2020-01-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. EMILY ARNOULD, RN BSN
- Address
- 2100 WINCHESTER RD NEENAH WI 54956 US
- Phone
- 920-920-9207
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | POISE IMPRESSA : PESSARY, VAGINAL : HHW | PESSARY, VAGINAL | K-C AFC MANUFACTURING, S. DE R.L. DE C.V | HHW | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-27 | 0 |
Event Narratives#
D
Patient 1
THIS IS A NON-US EVENT. THIS EVENT OCCURRED IN (B)(6). CONSUMER REPORTED THE STRINGS DETACHING FROM THE PESSARIES PRIOR TO USE. NO FURTHER INFORMATION HAS BEEN RECEIVED.