MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 3 manufactured by K-c Afc Manufacturing, S. De R.l. De C.v.
[176297494]
Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[176297495]
Consumer reported the petals of the insertion tubes for three pessaries were bent outward prior to use. No further information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011109575-2020-00478 |
| MDR Report Key | 9629031 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2015-11-23 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. EMILY ARNOULD, RN BSN |
| Manufacturer Street | 2100 WINCHESTER RD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207213128 |
| Manufacturer G1 | K-C AFC MANUFACTURING, S. DE R.L. DE C.V |
| Manufacturer Street | CALZADA INDUSTRIAL DE LAS MAQUILADORAS #87 NUEVO NOGALES |
| Manufacturer City | NOGALES, SONORA MEXICO 84094 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84094 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POISE IMPRESSA : PESSARY, VAGINAL : HHW |
| Generic Name | PESSARY, VAGINAL |
| Product Code | HHW |
| Date Received | 2020-01-24 |
| Model Number | SIZE 3 |
| Lot Number | NN532771A0744 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | K-C AFC MANUFACTURING, S. DE R.L. DE C.V |
| Manufacturer Address | CALZADA INDUSTRIAL DE LAS MAQUILADORAS #87 NUEVO NOGALES NOGALES, SONORA MEXICO 84094 MX 84094 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |