PRIMUS (THE BTE WS30)
Received Jun 18, 2012 · Event occurred Feb 23, 2012
Report 1119903-2012-00001 · MDR key 2625719
Device
Product problems
- Insufficient Device Problem Information
Patient
24 YR
- Head Injury
- Injury
Narrative
Description of Event or Problem
THE PT WAS INJURED USING AN ATTACHMENT (TOOL 901) DURING A SHOVEL EXERCISE DUE TO A REPORTED SUDDEN LOSS OF RESISTANCE. THE EXERCISE WAS CONDUCTED AS PART OF THERAPY FOR RUPTURE OF THE ACL, RIGHT SIDE. THE PT HEAD CAME IN CONTACT WITH THE LEVER ARM OF THE TOOL. THE PT REC'D THREE (3) STITCHES ON THE FOREHEAD. HOSPITALIZATION WAS NOT REQUIRED AND THE INDIVIDUAL INVOLVED RETURNED TO CONTINUE TREATMENT AT THE CLINIC. HIS TREATMENT DATES ARE FROM (B)(6) 2012, SEVERAL TIMES PER WEEK.
Additional Manufacturer Narrative
(B)(4). ONCE BTE PERSONNEL BECAME AWARE OF THE INCIDENT IT WAS PROMPTLY REVIEWED, EVALUATED, AND INVESTIGATED. BTE PERSONNEL SPOKE WITH THE CLINIC AND THE DEVICE DISTRIBUTOR STAFF SEVERAL TIMES TO INQUIRE ABOUT THE PT'S STATUS. THE PT REC'D THREE (3) STITCHES ON THE FOREHEAD, DID NOT SEEK ANY ADD'L MEDICAL ATTENTION AND RETURNED TO THE SAME CLINIC TO CONTINUE THERAPY. BASED ON THE INFO OBTAINED, AND AS UNFORTUNATE AS THIS EVENT WAS, AN IN VIEW OF THE DEFINITION OF SERIOUS INJURY, WE DID NOT DEEM THAT THIS MET THE REPORTING REQUIREMENTS. IT WAS CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION. IN SUMMARY, THE QUALITY MANAGER BELIEVED THAT NONE OF THE CRITERIA FOR SUBMITTING A 30 DAY REPORT HAD BEEN MET: IT WAS NOT A SERIOUS INJURY AND THE DEVICE DID NOT MALFUNCTION. CONSEQUENTLY, THE DECISION NOT TO FILE A REPORT WITH THE FDA WAS MADE.