MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-01-31 for DURASPHERE INJECTABLE BULKING AGENT 030966 manufactured by Carbon Medical Technologies, Inc..
[98669719]
Durasphere exp injectable bulking agent is a sterile, nonpyrogenic, single patient use device that is injected sub-mucosally at the bladder neck in the treatment of adult women with stress urinary incontinence due to intrinsic sphincteric deficiency. The potential for development of a delayed onset abscess at the site of injection is a known, inherent risk with this type of procedure and is documented within the device labeling. The device was not returned for evaluation. Biocompatibility testing has been conducted and has determined that the device is non-immunogenic. The device history record was not reviewed because lot identification information could not be obtained. Appropriate controls are in place to ensure that no discrepancies exist before release, including packaging and sterilization records.
Patient Sequence No: 1, Text Type: N, H10
[98669720]
Patient developed a delayed onset abscess at site of injection (intravaginal) approximately 3 years post-injection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134494-2017-00002 |
| MDR Report Key | 7230701 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-11-22 |
| Date Added to Maude | 2018-01-31 |
| 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 | MR. ANDREW ADAMS |
| Manufacturer Street | 1290 HAMMOND ROAD |
| Manufacturer City | SAINT PAUL MN 551105876 |
| Manufacturer Country | US |
| Manufacturer Postal | 551105876 |
| Manufacturer Phone | 6516538512 |
| Manufacturer G1 | CARBON MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Street | 1290 HAMMOND ROAD |
| Manufacturer City | SAINT PAUL MN 551105876 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551105876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASPHERE INJECTABLE BULKING AGENT |
| Generic Name | INJECTABLE BULKING AGENT |
| Product Code | LNM |
| Date Received | 2018-01-31 |
| Catalog Number | 030966 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARBON MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 1290 HAMMOND ROAD SAINT PAUL MN 551105876 US 551105876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-31 |