MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for BARRIER RECTANGLE - 50MM X 76M 8312 manufactured by Stryker Leibinger Freiburg.
[63818124]
Patient Sequence No: 1, Text Type: N, H10
[63818125]
It was reported that the physician stated the patient came in with inflammation and irritation around the eye where the product was implanted. No replacement was needed at the time and the product will not be returned. Also, it is unknown if the implant is the cause of the inflammation. It was additionally reported that the patient was diagnosed with a hematoma and was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[63819278]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[63819279]
It was reported that the physician stated the patient came in with inflammation and irritation around the eye where the product was implanted. No replacement was needed at the time and the product will not be returned. Also, it is unknown if the implant is the cause of the inflammation. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00308 |
| MDR Report Key | 6212310 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-29 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-12-02 |
| Date Added to Maude | 2016-12-29 |
| 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 | MR. HANS GEIGER |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARRIER RECTANGLE - 50MM X 76M |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2016-12-29 |
| Catalog Number | 8312 |
| Lot Number | G003755 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |