MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-26 for SIZE NO. 1 - 16MM X 23MM X 7MM 7238 manufactured by Stryker Orthobiologics-malvern.
[65900756]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[65900757]
It was reported by a physician that a patient had swallowed the nostril retainers that were utilized in a procedure. It was further reported that the nostril retainers passed through the patient naturally and the patient was otherwise unharmed. There were no medical intervention, or surgical delay due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00021 |
| MDR Report Key | 6281412 |
| Date Received | 2017-01-26 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-01-26 |
| 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 | 0 |
| Brand Name | SIZE NO. 1 - 16MM X 23MM X 7MM |
| Generic Name | DEVICE |
| Product Code | LYA |
| Date Received | 2017-01-26 |
| Catalog Number | 7238 |
| Lot Number | UNKNOWN |
| 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 ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-26 |