MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-29 for BIOINDUCTIVE IMPLANT - MEDIUM 2169-2 manufactured by Rotation Medical.
[134374041]
Date of event provided ((b)(6) 2018) is approximate as an exact date was not provided for the "aspiartion" procedure (6-7 weeks post-operatively). Investigation narrative: a review of the device history records for this device confirmed the lot to be sterile. Additional information has been requested from the complainant regarding this incident and the investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[134374042]
It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen. The physician aspirated a large amount of pus from the patients shoulder. Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection. It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection. Current patient status is unknown, however, no further complications have been reported. Report 1 of 2 to capture medical intervention (aspiration) that occurred 6-7 weeks post-operatively. See related report 3009351468-2019-00002 for 2nd event (i&d wash out/removal procedure) that occurred on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00001 |
| MDR Report Key | 8285867 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-01-02 |
| Date Added to Maude | 2019-01-29 |
| 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. GARRETT AHLBORG |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7637467531 |
| Manufacturer G1 | ROTATION MEDICAL |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOINDUCTIVE IMPLANT - MEDIUM |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-01-29 |
| Catalog Number | 2169-2 |
| Lot Number | RC2AN18K4 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL |
| Manufacturer Address | 15350 25TH AVENUE NORTH SUITE 100 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-29 |