81/83/2613 12:51 18883328178 MED GE 19/28 u.e. Dopanmonl oi Heath and Humafl Services Form Approved: OMB For reporting 5 ED adverse events. product problems and mm The FDA Sat ty Inforrnati product use mm "mm (3 a on an Internet submission -- Page 1/2' 7 Advarae Event Reporting Pragtam A, PATIENT INFOHMATIOFJ 0. 5-USPEKIT hf . . 1. 155 5 Ha.-azanornn plus ?2 2 Dale ur Amount Frequency Home Check anhetaoviy: 1 1. Auvma Even: "1 i Pru-duct Um em Pluhlum nrsuna ,Cfutcolnwa ta Adverse Ewan: (Shack air that ., a. gauze>>: ohm? Ifunxnawn. give dwaiion) rmmno for 5. Evan: I-bmu After Una st 3 Damn: or Petmanoni Damage or 99" Dam! - as/n1;2a12 1o!o7f2u12 :1 Ya: No My Lisumamning connanlm Detect 1 Ij Oinarsamua tlmonam Madlcal Es-ants) '3 mm" #2 Yes No wpg," Reuuirod Imanranfion In mufrrmonummaga (Damn) 593Evan: -1. Duo Report *1 gum, ozzozxaoaa #2 umw 5. {inscribe Eucnt, Premium or Product Una Error 5. Lot 3 Explmilnn Bus *2 :1 N: Egan': Pt'. was taking a supplement called 2.-aumofan :1 9953'5'm9" #1 .9. NBC mr urique so plus which we 1391 ioved suppressed her :2 :2 irrmunue system. This product was obtained through a. distribute: in the. husband, who was also taking the product: daveloped am difficle colitis and died in April 2012. We believe she was ct:-lonized with the Difficle and after taking an antibiotic dava-leaped severe colitis. Shea underwent colacnamsy ?43: the infienction but <>! 6000 mi conatiiuta an admission that median! porwnnal or 111-: product caused or 1o want. 001