MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE 92-13 manufactured by D.o.r.c Dutch Ophthalmic International Bv.
[102716101]
Lot review: there is nothing relative to the complaint. The material used is medical grade implantable silicone. After testing the root cause is inconclusive for an allergic reaction. This complaint is considered an isolated incident. Sample analysis: no sample was received. Conclusion: the complaint is not confirmed. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b. V. ). Details of this activity were discussed with cdrh office of compliance (b)(6) during a tele-conference on (b)(6)2017. All available information has been disclosed. This complaint has now been closed. Please note that 2 mdrs submitted for the 2 parts that were used together in the implant 1222074-2018-00052 and 1222074-2018-00053.
Patient Sequence No: 1, Text Type: N, H10
[102716102]
It was reported a patient had a scleral buckle implanted in right eye one year ago. The patient reportedly had an allergic reaction on the skin surrounding her eye and was seen by a dermatologist. The patient was evaluated for a possible allergic reaction related to silicone. It was reported the md wants to perform an allergy test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00053 |
| MDR Report Key | 7346826 |
| Date Received | 2018-03-16 |
| Date of Report | 2015-02-04 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Date Added to Maude | 2018-03-16 |
| 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 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037538824 |
| Manufacturer G1 | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, NETHERLANDS |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE |
| Generic Name | SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE |
| Product Code | HQX |
| Date Received | 2018-03-16 |
| Catalog Number | 92-13 |
| Lot Number | 161019 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-16 |