MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-10 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[4272466]
It was reported that the patient underwent a procedure for dlif at l2-3. The surgeon used a light source and when it was removed from the tube the surgeon placed the light source on the drape which subsequently burned the patient on the shoulder area. The burn was treated and there were no further complications.
Patient Sequence No: 1, Text Type: D, B5
[11812526]
(b)(4). Location: hospital. The device was not returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-02142 |
| MDR Report Key | 3738344 |
| Report Source | 05,07 |
| Date Received | 2014-04-10 |
| Date of Report | 2014-03-11 |
| Date of Event | 2014-03-11 |
| Date Mfgr Received | 2014-03-11 |
| Device Manufacturer Date | 2013-12-04 |
| Date Added to Maude | 2014-04-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2014-04-10 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | 0292423W |
| Device Expiration Date | 2018-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-10 |