MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-03-13 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[102204336]
There is no clear linkage at this point between the patient's implantation of mpq and her reaction, however the patient has requested a sample of the product so it can be used to either identify what she is allergic to in mpq, or rule it out. The incident is being reported due to the lack of information regarding the severity of the reaction and the likelihood it was related to mpq. We will continue to gather more information and add it as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[102204337]
A (b)(6) year-old female patient with a history of stress incontinence, post-menopausal bleeding and urge incontinence was implanted with macroplastique (mpq) implants on (b)(6) 2017. Forty-eight hours after the implantation, the patient experienced an allergic reaction which caused stiffness in her hands that progressed to increased pain in the joints of her hands. The patient's hands became extremely red and were hot to the touch. A doctor prescribed the patient with a 3 day course of 60 mg of prednisone. Patient stated she felt better the morning after taking the prednisone. The bulking agent is still implanted in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00005 |
| MDR Report Key | 7333677 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-09 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-03-13 |
| 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. NICOLE BOSER |
| Manufacturer Street | 5420 FELTL ROAD |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9524266141 |
| Manufacturer G1 | UROPLASTY, LLC |
| Manufacturer Street | 5420 FELTL ROAD |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MACROPLASTIQUE IMPLANTS |
| Generic Name | URETHERAL BULKING AGENT |
| Product Code | LNM |
| Date Received | 2018-03-13 |
| Model Number | MPQ-2.5 |
| Catalog Number | MPQ-2.5 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROPLASTY, LLC |
| Manufacturer Address | 5420 FELTL ROAD MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-13 |