MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for T-MAX 7210551 manufactured by Smith & Nephew, Inc..
[183896777]
Patient came into operating room for procedure at 0745, patient was positioned by the providers and staff in the standard position for a shoulder procedure. Procedure was completed and patient was transferred to pacu at 1239. When patient awoke from his procedure, he noticed a bump on the back of his head. The patient was monitored and the bump on the patient's head was documented as well as the redness on forehead and chin from the tenant face mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847493 |
| MDR Report Key | 9847493 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-11-01 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-MAX |
| Generic Name | ACCESSORIES, OPERATING-ROOM, TABLE (KIT) |
| Product Code | FWZ |
| Date Received | 2020-03-18 |
| Catalog Number | 7210551 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |