BRTClass I
Restraint, Patient, Conductive
General Hospital · 21 CFR 880.6760
MDR events28All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
28 adverse event reports on file
- SYNCHROMED IIIJun 4, 2025InjuryMedtronic Puerto Rico Operations Co.3004209178-2025-09488
- UNKNOWN MICROCUFFDec 15, 2021MalfunctionAvanos9611594-2021-00185
- 1.5MM GUIDE WIREOct 7, 2019MalfunctionSmith & Nephew, Inc.1219602-2019-01211
- HOLDER LEGMay 16, 2017MalfunctionSmith & Nephew, Inc.1219602-2017-00495
- REXXApr 7, 2014InjuryM. C. Healthcare Products (a Division Of Span Medical Products)1041130-2014-00001
- LEATHER RESTRAINTSJan 14, 2008Death997122
- *Apr 19, 2006Death*705600
- PROFLEX RESTRAINT STRAPOct 23, 1997InjuryProfessional Specialties Co., Inc.128266
- Unnamed deviceOct 23, 19971043615-1997-90001
- ADAPT-ITJun 30, 1997InjuryWft/aquaplast Corp.104030
Event type breakdown
Death18
Injury6
Malfunction3
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.