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e∙Sense
PendraCare International B.V. · Model Bladder & Urethral Dual Sensor Catheter, straight tip shape · UDI-DI 08718122028339
FEN
Prescription
10
510(k) clearances
119
Adverse events (1 deaths)
3
Recalls
56
Facilities
Description
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-17 | LABORIE MEDICAL TECHNOLOGIES, CORP | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to |
| 2018-07-03 | ConvaTec, Inc | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. |
| 2006-10-04 | Laborie Medical Technologies | Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M |
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