MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-21 for SOLESTA INJECTABLE GEL manufactured by Bausch + Lomb.
[92738605]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of this investigation.
Patient Sequence No: 1, Text Type: N, H10
[92738606]
Reportedly the patient had an anal mass removed a few years post dextranomer/hyaluronic acid (dx/ha) injection. Pathologist believed that the removed mass is the injected gel migrated from the initial point of injection. The details of the surgery were not provided. Additional information regarding this event was requested but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2017-00040 |
| MDR Report Key | 7051380 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-21 |
| Date of Report | 2017-10-23 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-21 |
| 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. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | Q-MED |
| Manufacturer Street | SEMINARIEGATAN 21 |
| Manufacturer City | UPPSALA 75228 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 75228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLESTA INJECTABLE GEL |
| Generic Name | AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE |
| Product Code | LNM |
| Date Received | 2017-11-21 |
| Model Number | SOLESTA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-21 |