FDA.reportPublic FDA data

MAUDE MDR 2620792

MDR report key
2620792
Report number
2939821-2012-00017
Event key
0
Event type
3
Date of event
2009-01-07
Date received
2012-06-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
8100 CAMINO ARROYO GILROY CA 93101 US
Phone
800-800-8008
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NORCO EXERCIS LOOP ATTACHMENTDOOR ANCHORNORTH COAST MEDICAL, INC.IONNC91231-50NC91231-50NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-0801. O

Event Narratives#

D

Patient 1

(B)(6) 2009, WHILE VACATIONING AT (B)(6), PT WAS PERFORMING EXERCISES PRESCRIBED BY OPTM SPORTS THERAPY USING THERA-BAND EXERCISE 24 BANDS AND A NORTH COAST EXERCISE LOOP (AKA THE DOOR ANCHOR). WHILE PERFORMING THE PRESCRIBED EXERCISES, THE NORTH COAST EXERCISE LOOP SNAPPED THROUGH THE DOOR AND STRUCK PT'S LEFT EYE.