MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-06 for SOLESTA INJECTABLE GEL manufactured by Bausch + Lomb.
[110280035]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[110280036]
It was reported that a patient was hospitalized for 5 days after receiving a solesta injection due to a reaction and a cyst. The patient alleged that he "probably had an ulcer that never manifested itself but solesta exacerbated it" and that this probably occurred from straining while attempting to have a bowel movement. The patient is said to be making an appointment with a doctor. Additional information was requested, but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2018-00013 |
| MDR Report Key | 7575139 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-09 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2016-07-06 |
| Date Added to Maude | 2018-06-06 |
| 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 AB |
| 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 | 2018-06-06 |
| Lot Number | 14711 |
| ID Number | NI |
| Device Expiration Date | 2019-06-30 |
| Operator | PHYSICIAN |
| 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. Hospitalization | 2018-06-06 |