MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for RESURE SEALANT manufactured by Ocular Therapeutix.
[100888740]
Despite multiple requests for additional information, ocular therapeutix (otx) has not received additional information. Otx does not have any information on the physician(s) who applied resure, the patients who may have experienced endophthalmitis, if serious injury occurred, or if the physician(s) believe resure sealant caused or contributed to the injury. Based on this information, there is insufficient information for us to determine if there is a change to the risk profile of resure. Follow-up reports will be submitted in accordance with 21 cfr part 803. 56 if additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[100888741]
In follow-up to a medical information request, a physician reported that there were two patients with endophthalmitis and both patients were treated with resure sealant. Otx was unable to collect additional information despite multiple attempts to follow-up with the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008477155-2018-00001 |
| MDR Report Key | 7293906 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-23 |
| 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. ELIZABETH FENNA |
| Manufacturer Street | 15 CROSBY DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7813574056 |
| Manufacturer G1 | OCULAR THERAPEUTIX |
| Manufacturer Street | 36 CROSBY DRIVE SUITE 101 |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESURE SEALANT |
| Generic Name | RESURE SEALANT |
| Product Code | PFZ |
| Date Received | 2018-02-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OCULAR THERAPEUTIX |
| Manufacturer Address | 36 CROSBY DRIVE SUITE 101 BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-23 |