MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for FEMSOFT? INSERT FEMALE URETHRAL INSERT 72203 manufactured by C.r. Bard, Inc. (covington) -1018233.
[104802992]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[104802993]
It was reported that the femsoft device could not be located for removal. The complainant stated that she inserted the device on (b)(6) 2018, but noticed that it felt uncomfortable shortly after placement. Two hours later, she decided to remove the device but could not grasp it for removal. She also reported that she is an experienced user with this device and has been using it for several years without any previous issues. On the following day, (b)(6) 2018, she visited her doctor? S office who recommended that she go to the emergency room as a concern that the device may still be inside of her. Upon arrival, the hospital decided to admit her so that they could run further tests to locate the device. A pelvic x-ray was performed which revealed negative results. However; a ct scan of her abdomen/pelvis was performed on (b)(6) 2018 which did reveal a foreign object. The urologist then performed a procedure through her urethra to remove the device and she was later discharged from the hospital. Records indicate that this product was last sold to the complainant on (b)(6) 2014. Based on document # (b)(4), the product has been discontinued and has not been manufactured since the acquisition of (b)(6) medical by c. R. Bard, which occurred in (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01138 |
| MDR Report Key | 7410045 |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2013-07-12 |
| Date Added to Maude | 2018-04-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FEMSOFT? INSERT FEMALE URETHRAL INSERT |
| Generic Name | FEMSOFT INSERT |
| Product Code | OCK |
| Date Received | 2018-04-09 |
| Returned To Mfg | 2018-04-12 |
| Model Number | 72203 |
| Catalog Number | 72203 |
| Lot Number | 53500824 |
| Device Expiration Date | 2018-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-09 |