Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. UNKNOWN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Loss of Range of Motion (2032); Weakness (2145)
Event Date 02/08/2018
Event Type  Injury  
Event Description
It was reported that patient continued with right shoulder weakness and decreased range of motion, that was treated with a revision surgery.
 
Manufacturer Narrative
Neither valid lot number or product code were reported.Clinical details were quite limited.No product was returned, therefore physical evaluation, full investigation or definitive conclusions were impossible.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use which includes recommendations, precautionary statements and instructions for proper use of product.If objective evidence or relevant information becomes available to assist with evaluation the complaint will certainly be revisited.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
MDR Report Key8628643
MDR Text Key145673354
Report Number1219602-2019-00581
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K093897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup
Report Date 07/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
-
-