MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-02-20 for FEMSOFTINSERT 72201 manufactured by Rochester Medical Corp..
[5545373]
It was reported that the device was found inside the patient's bladder during a routine ultrasound. A previous ultrasound in (b)(6) 2014 did not show the device. The patient had experienced a uti and some bleeding prior to discovery, but the patient and her mother had been unaware that the device was missing until the scan. The patient had been prescribed the device was treatment for stress urinary incontinence, as the patient has been diagnosed with spinia bifida with neurogenic bladder and bowel, and is not confirmed to a wheelchair. The patient has been inserting the device herself for several months, prior to this her mother had been inserting them for her. The device was removed from the bladder via cystoscopy. A large stone was noted on one end. Antibiotics were given prophylactically.
Patient Sequence No: 1, Text Type: D, B5
[13017556]
The device was not returned for evaluation, however a photo of the device following removal from the patient was made available. The lot number is unknown; therefore, the device history record could not be reviewed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2015-00052 |
| MDR Report Key | 4539093 |
| Report Source | 01,04 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2015-02-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTY LEWIS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | ROCHESTER MED. CORP. |
| Manufacturer Street | ONE ROCHESTER MED. DR. |
| Manufacturer City | STEWARTVILLE MN 5597 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMSOFTINSERT |
| Product Code | OCK |
| Date Received | 2015-02-20 |
| Model Number | NA |
| Catalog Number | 72201 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHESTER MEDICAL CORP. |
| Manufacturer Address | STEWARTVILLE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4161025 | 1. Required No Informationntervention | 2015-02-20 |