MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-01 for ESTEEM MANUAL 1130 N/A manufactured by Pos-t-vac Medical.
[125821201]
Patient reports that when transferring the tension ring to the base of his penis, his testicles were sucked into the tube right when he transferred the ring. After the ring was fully off the tube and onto the patient is when he realized that his testicles were in the ring as well. He believes he was using the smallest ring but was not sure. When trying to remove the ring, he had to pull both of his testicles out of the ring to allow for the ring to be removed from his penis. He was sore for a few days afterwards and thought the pain would subside with time but he reports that it only got worse. He is having trouble getting up from a seated position or when lying down. The patient did return the device and all of the components as requested. The returned box included 1-esteem manual pumphead, 1- standard penile tube, 1-ringloader, 2-comfort insert, 1-tube of lubricant, 4-pressure point tension rings size a, b, c and d, 1-black storage bag, and 1-instructional video. The general manager preformed the testing on the device and components. The pumphead was tested and performed according to fda standards. Pressure point tension rings were examined, tested and appear to have no defects, deformities or tears. Device and pressure point tension rings work as they were designed and for intended use. All other components were inspected and there were no defects or deformities. There was no malfunction of the device or components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931563-2018-00002 |
| MDR Report Key | 8028878 |
| Report Source | CONSUMER |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-14 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2018-07-13 |
| Date Added to Maude | 2018-11-01 |
| 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 | MS. CARA SLOVACEK |
| Manufacturer Street | 2111 W. WYATT EARP BLVD. |
| Manufacturer City | DODGE CITY KS 67801 |
| Manufacturer Country | US |
| Manufacturer Postal | 67801 |
| Manufacturer Phone | 6203384126 |
| Manufacturer G1 | POS-T-VAC MEDICAL |
| Manufacturer Street | 2111 W. WYATT EARP BLVD |
| Manufacturer City | DODGE CITY KS 67801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 67801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM MANUAL |
| Generic Name | ESTEEM MANUAL |
| Product Code | LKY |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-19 |
| Model Number | 1130 |
| Catalog Number | N/A |
| Lot Number | M-2018-0713 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POS-T-VAC MEDICAL |
| Manufacturer Address | 2111 W. WYATT EARP BLVD DODGE CITY KS 67801 US 67801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-01 |