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 2018-06-11 for SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE 92-50-5 manufactured by Dutch Opthalmic Research Center Bv.
[110703553]
The investigation has begun. Device history lot review: there was nothing relative to this complaint. This lot met both sterility and bacterial endotoxin test reports. Results pass requirements. Unused samples were returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[110703554]
A user facility has reported a surgical removal of an eye implant due to infection and extrusion. The initial date of surgery for a retinal detachment occurred on (b)(6) 2017 for placement of this device. Then on (b)(6) 2018 the scleral buckle was removed for infection and extruding. The device was removed and then sent to pathology. It was reported pathology report indicated occasional gram + cocci. The patient was treated with antibiotics. The incident has fully resolved. The facility has returned unused samples from this lot for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00174 |
| MDR Report Key | 7588927 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-11 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-06-11 |
| 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 LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR BLDG 1 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE |
| Generic Name | SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE |
| Product Code | HQX |
| Date Received | 2018-06-11 |
| Returned To Mfg | 2018-07-03 |
| Catalog Number | 92-50-5 |
| Lot Number | 1007046 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-11 |