MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for TRENGUARD 55201 manufactured by Dan Allen Surgical.
[143239539]
A patient complained of a headache after their procedure and had a bump on her head. The patient was given an ice pack to put on her head and appeared to be ok. Patient was discharged home. Patient then contacted hospital to say she had developed a scab on the top of her head. Roughly a week after the procedure, patient had minimal hair loss at the top of the head. Three weeks after the procedure the patient displayed significant hair loss at the top of the head. As of last month, the patient's hair has not regrown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8554531 |
| MDR Report Key | 8554531 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-09-28 |
| Report Date | 2019-03-13 |
| Date Reported to FDA | 2019-03-13 |
| Date Reported to Mfgr | 2019-04-26 |
| Date Added to Maude | 2019-04-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TRENGUARD |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2019-04-26 |
| Catalog Number | 55201 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAN ALLEN SURGICAL |
| Manufacturer Address | 12373 KINSMAN RD. BUILDING C SUITES 1 - 9 NEWBURY OH 44065 US 44065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |