There was/were 2 case(s) with a sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of cause not established.There was/were 1 case(s) with a sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of cause cannot be traced to device.There was/were 2 case(s) with no sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of cause not established.There was/were 1 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of cause not established.There was/were 2 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of no problem detected.There was/were 1 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of cause cannot be traced to device.There was/were 13 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of cause not established.There was/were 122 case(s) with no sample received for evaluation, a result code of no findings available and a conclusion code of cause not established.There was/were 1 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of failure to follow instructions.There was/were 1 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of cause traced to manufacturing.There was/were 2 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of cause cannot be traced to device.There was/were 1 case(s) with no sample received for evaluation, a result code of operational problem identified and a conclusion code of cause not established.There was/were 13 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause not established.There was/were 5 case(s) with no sample received for evaluation, a result code of operational problem identified and a conclusion code of cause cannot be traced to device.There was/were 3 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of cause cannot be traced to device.There was/were 51 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause cannot be traced to device.There was/were 9 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of failure to follow instructions.There was/were 3 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of failure to follow instructions.There was/were 6 case(s) with no sample received for evaluation, a result code of operational problem identified and a conclusion code of failure to follow instructions.There was/were 1 case(s) with a sample received for evaluation, a result code of improper material and a conclusion code of cause not established.There was/were 1 case(s) with no sample received for evaluation, a result code of improper material and a conclusion code of cause cannot be traced to device.There was/were 4 case(s) with no sample received for evaluation, a result code of improper material and a conclusion code of failure to follow instructions.There was/were 2 case(s) with a sample received for evaluation, a result code of improper material and a conclusion code of cause cannot be traced to device.There was/were 5 case(s) with a sample received for evaluation, a result code of improper material and a conclusion code of failure to follow instructions.There was/were 1 case(s) with a sample received for evaluation, a result code of packaging problem identified and a conclusion code of cause traced to manufacturing.There was/were 2 case(s) with a sample received for evaluation, a result code of manufacturing process problem identified and a conclusion code of manufacturing deficiency.There was/were 1 case(s) with a sample received for evaluation, a result code of manufacturing process problem identified and a conclusion code of cause traced to manufacturing.(b)(4).
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This report summarizes (b)(4) 224 reported events for q1 2019.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 31 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 4 female, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 16 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 4 female, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 6 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 unknown gender, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 70 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 2 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 4 female, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 5 male, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective component.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 2 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 3 female, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 5 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted / bent.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code material twisted / bent.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted / bent.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material too rigid or stiff.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code material too rigid or stiff.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device problem.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 6 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material split, cut or torn.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material deformation.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device damaged by another device.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code optical discoloration.
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