MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-11 for FLYTE SURGICOOL TOGA, 2XL, ZIPPER 0408841000 manufactured by Stryker Instruments-kalamazoo.
[178589387]
It was reported that during a surgical procedure at the user facility, the gown split at the seam on the right arm. The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[188148962]
Device evaluation: follow-up report submitted to document device evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[188148983]
It was reported that during a surgical procedure at the user facility, the gown split at the seam on the right arm. The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00450 |
| MDR Report Key | 9694377 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-02-11 |
| 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. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLYTE SURGICOOL TOGA, 2XL, ZIPPER |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2020-02-11 |
| Catalog Number | 0408841000 |
| Lot Number | 19091852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |