MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for POISE IMPRESSA : PESSARY, VAGINAL : HHW SIZE 3 manufactured by K-c Afc Manufacturing, S. De R.l. De C.v.
[183652729]
Review of the device history record (dhr), supporting quality records, and unused companion samples confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[183652730]
The consumer reported that part of the outer fabric of the bladder support was missing after removal and the inner silicone was exposed. She did not seek medical attention but called her doctor to inform them what happened. Consumer stated she was doing fine after her experience with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011109575-2020-00632 |
| MDR Report Key | 9836251 |
| Report Source | CONSUMER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-09-02 |
| Date Added to Maude | 2020-03-16 |
| 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 | 2020-03-16 |
| Returned To Mfg | 2020-03-09 |
| Model Number | SIZE 3 |
| Lot Number | NN824671A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-16 |